AIOMEGA® AIO BREATHE®: FDA CLEARED FOR PEDIATRIC & ADULT OBSTRUCTIVE SLEEP APNEA
Unified Adult & Pediatric Airway Platform for Your Practice
A clinician‑directed digital workflow for evaluating, prescribing, and managing custom‑fabricated intraoral devices for children (ages 6-17) and adults (18+).
AIOMEGA® provides clinicians with a structured, fully digital pathway for evaluating, prescribing, and managing a custom intraoral device. The platform integrates clinician‑submitted records, structured prescription parameters, and precision digital fabrication to ensure each device reflects the exact specifications defined by the prescribing clinician. Throughout the process, clinicians maintain full authority over diagnostic interpretation, treatment planning, and therapeutic decisions, while AIOMEGA® supports consistency, clarity, and fabrication accuracy.
AIO devices are manufactured through a dentist‑driven, growth‑responsive workflow that adapts to each stage of craniofacial development in pediatric patients (ages 6–17) while maintaining a unified platform for adults and children.
The following 6‑Step Clinical Workflow outlines how AIOMEGA® fits into clinical practice — from initial evaluation through follow‑up and ongoing support.
AIO Breathe® Clinician Workflow
Step 1 : Patient Evaluation
Step 2: Records & Prescription (with AIO‑Rx™ SMART‑Rx™)
Step 2: Records & Prescription (with AIO‑Rx™ SMART‑Rx™)
During the patient evaluation, the clinician determines whether a prescription oral device is appropriate based on their professional assessment. This evaluation may include:
- Review of medical and dental history
- Examination of craniofacial and intraoral structures
- Assessment of airway‑related anatomy
- Imaging, if the clinician considers it rel
During the patient evaluation, the clinician determines whether a prescription oral device is appropriate based on their professional assessment. This evaluation may include:
- Review of medical and dental history
- Examination of craniofacial and intraoral structures
- Assessment of airway‑related anatomy
- Imaging, if the clinician considers it relevant
- Any diagnostic tools the clinician chooses to use
Clinicians may perform pre‑treatment sleep testing to document baseline sleep‑related parameters prior to prescribing an oral device. These baseline measurements help the clinician understand the patient’s starting point and guide treatment planning.
After the device is delivered and used as prescribed, clinicians may also perform post‑treatment sleep testing to assess physiological changes and evaluate treatment efficacy based on their clinical judgment. The timing, type, and interpretation of sleep testing remain entirely at the discretion of the prescribing clinician.
All diagnostic interpretation, treatment planning, and assessment of treatment response remain solely under clinician authority.
All decisions regarding candidacy, diagnostic interpretation, and treatment planning are made solely by the licensed clinician.
Step 2: Records & Prescription (with AIO‑Rx™ SMART‑Rx™)
Step 2: Records & Prescription (with AIO‑Rx™ SMART‑Rx™)
Step 2: Records & Prescription (with AIO‑Rx™ SMART‑Rx™)
During the records and prescription phase, the clinician provides the information required to fabricate the custom device. These records may include:
- Intraoral impressions or digital scans
- Bite registration or the prescribed mandibular position
- Vertical dimension specifications
- Any additional instructions needed for fabrication
Clinicians may
During the records and prescription phase, the clinician provides the information required to fabricate the custom device. These records may include:
- Intraoral impressions or digital scans
- Bite registration or the prescribed mandibular position
- Vertical dimension specifications
- Any additional instructions needed for fabrication
Clinicians may also use the AIO‑Rx™ SMART‑Rx™ system to organize and document the prescription parameters they select. This tool supports clear, clinician‑directed decision‑making and ensures all required inputs are captured before fabrication.
In addition to mandibular position and vertical dimension, the clinician also prescribes:
- The thickness of the tooth‑covering portion of the device
- The height and geometry of the mandibular plateau
These parameters directly influence the device’s structural configuration and are incorporated into the digital design exactly as prescribed.
The clinician’s selected mandibular position, vertical dimension, device thickness, and mandibular plateau specifications form the foundation of the device’s digital model. AIOMEGA® fabricates the device according to these clinician‑defined parameters.
All prescription decisions — including mandibular position, vertical dimension, device thickness, and plateau height — remain solely under clinician authority.
Step 3: Precision Digital Custom Fabrication
Step 2: Records & Prescription (with AIO‑Rx™ SMART‑Rx™)
Step 3: Precision Digital Custom Fabrication
During the custom fabrication phase, AIOMEGA® constructs the device using the exact records and prescription parameters submitted by the clinician. Each device is produced through a Precision Digital Custom Fabrication workflow that includes:
- Digital modeling based on clinician‑submitted scans or impressions
- Integration of the prescribed ma
During the custom fabrication phase, AIOMEGA® constructs the device using the exact records and prescription parameters submitted by the clinician. Each device is produced through a Precision Digital Custom Fabrication workflow that includes:
- Digital modeling based on clinician‑submitted scans or impressions
- Integration of the prescribed mandibular position
- Incorporation of the clinician‑selected vertical dimension
- Application of design features within the device’s mechanical range
In addition to mandibular position and vertical dimension, AIOMEGA® incorporates the clinician‑prescribed device thickness (tooth‑covering portion) and the clinician‑prescribed mandibular plateau height and geometry. These structural parameters directly influence the device’s engineered configuration and are integrated exactly as specified.
AIOMEGA® uses digital robotic‑precision customization to fabricate the device to exacting manufacturing standards based on the clinician’s prescribed specifications. Advancement measurements in 1/10th‑millimeter increments are incorporated into the manufacturing process, supporting consistency, structural integrity, and reproducibility.
Every device is made specifically for the individual patient according to the clinician’s instructions. All therapeutic decisions — including candidacy, mandibular position, vertical dimension, device thickness, and plateau height — remain solely under clinician authority.
Step 4 : Delivery & Fitting
Step 5: Follow-up & Monitoring
Step 3: Precision Digital Custom Fabrication
During the delivery and fitting appointment, the clinician evaluates how the AIOMEGA® device seats, adapts, and functions intraorally. This visit ensures that the device reflects the clinician’s prescribed parameters and is comfortable for the patient. The fitting process may include:
- Verifying adaptation of the device to the dentition
- Asse
During the delivery and fitting appointment, the clinician evaluates how the AIOMEGA® device seats, adapts, and functions intraorally. This visit ensures that the device reflects the clinician’s prescribed parameters and is comfortable for the patient. The fitting process may include:
- Verifying adaptation of the device to the dentition
- Assessing retention, stability, and overall seating
- Confirming the prescribed mandibular position
- Checking vertical dimension and occlusal contacts
- Inspecting the tooth‑covering thickness and plateau geometry as fabricated
- Reviewing insertion, removal, and home‑care instructions with the patient
The clinician may make chairside adjustments to optimize comfort or refine the seating characteristics of the device. These adjustments remain within the clinician’s professional judgment and do not alter the underlying prescribed parameters unless the clinician elects to modify them.
All fitting decisions — including comfort optimization, seating evaluation, and any adjustments — remain solely under clinician authority.
Step 5: Follow-up & Monitoring
Step 5: Follow-up & Monitoring
Step 5: Follow-up & Monitoring
After the device is delivered, clinicians monitor patient progress and determine whether adjustments or additional evaluations are needed. Follow‑up visits allow the clinician to assess comfort, function, and the patient’s response to therapy. This may include:
- Evaluating comfort, tolerance, and adherence
- Reviewing patient‑reported changes
After the device is delivered, clinicians monitor patient progress and determine whether adjustments or additional evaluations are needed. Follow‑up visits allow the clinician to assess comfort, function, and the patient’s response to therapy. This may include:
- Evaluating comfort, tolerance, and adherence
- Reviewing patient‑reported changes in symptoms
- Inspecting device seating, retention, and wear patterns
- Assessing the mandibular position and vertical dimension in use
- Determining whether adjustments are clinically indicated
- Reinforcing proper insertion, removal, and home‑care instructions
Clinicians may also perform post‑treatment sleep testing to assess physiological changes and evaluate treatment efficacy based on their clinical judgment. The timing, type, and interpretation of sleep testing remain entirely at the discretion of the prescribing clinician.
If the clinician elects to modify the mandibular position, vertical dimension, device thickness, or plateau height, these adjustments are made according to the clinician’s prescription and professional assessment.
All follow‑up decisions — including adjustment strategy, timing of reassessment, and interpretation of post‑treatment testing — remain solely under clinician authority.
Step 6: Professional Resources
Step 5: Follow-up & Monitoring
Step 5: Follow-up & Monitoring
Clinicians have access to a comprehensive set of professional resources designed to support every stage of prescribing, delivering, and managing an AIOMEGA® device. These resources help ensure clarity, consistency, and confidence throughout the clinical workflow. Support may include:
- Technical assistance for digital scans, impressions, and
Clinicians have access to a comprehensive set of professional resources designed to support every stage of prescribing, delivering, and managing an AIOMEGA® device. These resources help ensure clarity, consistency, and confidence throughout the clinical workflow. Support may include:
- Technical assistance for digital scans, impressions, and record submission
- Guidance on prescription structuring using AIO‑Rx™ SMART‑Rx™ tools
- Support for interpreting device design files and digital previews
- Assistance with device insertion, seating characteristics, and adjustment considerations
- Educational materials for patient instruction and home‑care guidance
- Access to AIOMEGA® technical specialists for fabrication‑related questions
These resources are designed to complement — not replace — the clinician’s professional judgment. All diagnostic interpretation, treatment planning, and therapeutic decisions remain solely under clinician authority.
Pediatric Growth‑Phase Workflow (Ages 6–17)
AIO Breathe® PDS supports safe therapy during the dynamic years of craniofacial and dental development. This workflow outlines how clinicians monitor dentition, growth, and device fit throughout the pediatric lifecycle.
1️⃣ Initial Evaluation
Clinicians assess whether the child is an appropriate candidate for AIO Breathe® PDS.
Evaluation includes:
- Mixed dentition status (≥8 maxillary + ≥8 mandibular teeth)
- Jaw growth stage
- TMJ and periodontal health
- Airway and sleep‑study findings
- Behavioral and tolerance considerations
- This establishes a safe baseline for mandibular advancement.
2️⃣ Baseline Scans & Prescription Inputs
The IFU states: “Take an intra‑oral scan, impressions, or dental models… and send the prescription, scans, and patient information to AIOMEGA.”
Clinicians provide:
- Resting Advancement Position (RAP)
- Tray Thickness (TT)
- Mandibular Plateau (MP) selection
- Bite registration
- Full‑arch scans including gingiva
- These inputs define the child’s starting configuration before growth‑phase changes occur.
3️⃣ Growth‑Responsive Monitoring
This is the core of pediatric therapy — because it is monitoring growth, not modifying growth.
The IFU states: “When used with patients who may experience growth or changing dental alignment… it is important to take intraoral scans at regular intervals and submit each new scan to ensure timely fabrication of a new device.”
Clinicians monitor:
- Eruption of permanent teeth
- Exfoliation of primary teeth
- Arch width and shape
- Jaw growth
- Occlusal changes
- Device fit and comfort
- This ensures the device remains safe and properly fitted as the child grows.
4️⃣ Sequential Device Updates
As growth occurs, the device must be updated to maintain proper fit.
The IFU states: “If the device no longer fits properly due to growth or dental changes, order a new device to ensure safe and effective treatment.”
Common triggers for a new device:
- New permanent tooth eruption
- Loss of primary teeth
- Arch expansion
- Vertical occlusal changes
- Device looseness or pressure points
5️⃣ Follow-Up Every 30–60 Days
Routine follow‑ups allow clinicians to:
- Evaluate TMJ comfort
- Check for mucosal irritation
- Monitor dental changes
- Assess mandibular advancement
- Inspect and clean the device
- Confirm caregiver compliance
- Coordinate with the prescribing physician
- This cadence is fully supported by IFU language.
6️⃣ Caregiver Education & Home Monitoring
Parents play a central role in pediatric therapy.
Clinicians reinforce:
- Proper insertion and removal
- Daily cleaning
- Safe storage
- Reporting discomfort or tooth movement
- Monitoring nighttime tolerance
- Ensuring consistent use
- This supports safe, predictable therapy.
7️⃣ Transition to Adolescent Phase (12–17)
As the child enters adolescence:
- Growth rate may change
- Permanent dentition may change
- Device replacement frequency may change
- This transition is part of the natural pediatric lifecycle and is fully IFU‑aligned.
Indications for Use — pediatric & adult AIO Breathe® devices
Children: Age Category: 6-17 years
The AIO Breathe® PDS pediatric oral appliance is indicated for the treatment of:
- Mild to moderate obstructive sleep apnea (OSA) in pediatric patients ages 6 through 17.
- Primary snoring and upper airway resistance syndrome (UARS) in pediatric patients within the same age range.
- Pediatric patients who are intolerant of CPAP or have residual OSA after surgery, or surgery is contra-indicated or who require an oral appliance as part of a physician‑directed sleep treatment plan.
Use of the AIO Breathe® PDS device requires evaluation and ongoing supervision by a licensed dentist, in coordination with a sleep physician or ENT, consistent with pediatric standards of care.
Adults: Age Category: 18 years and older
The Adult AIO Breathe® adult oral appliance is indicated for the treatment of:
- Mild to moderate obstructive sleep apnea (OSA) in adults aged 18 and older.
- Primary snoring without OSA.
- Adult patients who are intolerant of CPAP or who prefer an oral appliance as an alternative therapy.
- Adult patients requiring mandibular advancement therapy as part of a physician‑directed sleep treatment plan.
Use of the AIO Breathe® device should be based on a physician’s diagnosis of sleep‑disordered breathing and delivered under the supervision of a licensed dentist trained in oral appliance therapy.
Patient Selection — Pediatric & adult AIO Breathe® devices
Age category: 6 - 17 years
Clinicians should evaluate the following when determining whether an adult patient is appropriate for treatment with AIO Breathe®:
- Dentition stability sufficient to support mandibular advancement
- Periodontal health adequate for appliance retention
- TMJ status, including absence of active joint pain or restricted opening
- Airway anatomy and sleep study findings consistent with mild–moderate OSA
- Ability to comply with device handling, hygiene, and follow‑up visits
- Absence of severe bruxism that may compromise device longevity
- Medical history supporting suitability for oral appliance therapy as an alternative to CPAP
Age category: 18 years and older
Clinicians should evaluate the following when determining whether an adult patient is appropriate for treatment with AIO Breathe®:
- Dentition stability sufficient to support mandibular advancement
- Periodontal health adequate for appliance retention
- TMJ status, including absence of active joint pain or restricted opening
- Airway anatomy and sleep study findings consistent with mild–moderate OSA
- Ability to comply with device handling, hygiene, and follow‑up visits
- Absence of severe bruxism that may compromise device longevity
- Medical history supporting suitability for oral appliance therapy as an alternative to CPAP
Contraindications — pediatric & Adult AIO Breathe® 18years a
Pediatric AIO Breathe®: General warnings and precautions
Contra-indications: The device is contraindicated for patients who: 1. have central sleep apnea. 2. have severe respiratory disorders. 3. have loose teeth or advanced periodontal disease. 4. are under the age of 6 years.
Warnings: Use of AIO BREATHE may cause: • Tooth movement or changes in dental occlusion. • Gingival or dental soreness. • Pain or soreness of the temporomandibular joint. • Excessive salivation. • Obstruction of oral breathing.
When AIO Breathe is used by patients who may experience growth or changing dental alignment or bite, such as pediatric or adolescent patient, it is important to take intraoral scans, impressions or models at regular intervals and submit each new scan, impressions or models to AIOMEGA to ensure timely fabrication of a new device and maintain therapeutic safety and effectiveness. Scans (or models) taken with braces or for sequential/transitional aligners may be submitted, provided they meet the specifications for AIO Breathe fabrication as described in section on ‘Directions for ordering AIO BREATHE’.
Precautions: Dentists should consider the medical history of their patients, including history of asthma, breathing, or respiratory disorders, or other relevant health problems, and refer the patient to the appropriate healthcare provider before prescribing the device. Patients should be evaluated for central sleep apnea which is an important contraindication for use of this device.
Adult AIO Breathe®: General warnings and precautions
Contraindications: AIO BREATHE should not be used by people who: • have central sleep apnea. • have severe respiratory disorders. • have loose teeth or advanced periodontal disease. • are under 18 years of age.
Warnings: Use of AIO BREATHE may cause: • Tooth movement or changes in dental occlusion. • Gingival or dental soreness. • Pain or soreness of the temporomandibular joint. • Excessive salivation. • Obstruction of oral breathing. If you notice any of the above conditions, please consult your dentist or healthcare professional immediately. If you experience pain or discomfort in the jaw joint area, stop wearing the device and talk to your Dentist.
AIOMEGA® biotechnology: design & manufacturing
Digital records & AIO‑Rx™ design
AIOMEGA® SMART® DIGITAL WORKFLOW
AIOMEGA® integrates a fully digital workflow with precision fabrication systems to support clinicians in prescribing and managing a custom intraoral device. The platform is built around clinician‑defined parameters, ensuring that every device reflects the exact specifications submitted in the prescription.
The technology ecosystem includes:
- Digital Records Integration — support for intraoral scans, impressions, bite registrations, and clinician‑defined measurements
- Structured Prescription Tools such as AIO‑Rx™ SMART‑Rx™, which help clinicians document mandibular position, vertical dimension, and device parameters with clarity
- Precision Digital Custom Fabrication, which produces devices according to the clinician’s submitted specifications
- Robotic‑assisted manufacturing ranges, engineered to maintain consistency across device components
- Digital previews and design confirmations to support clinician review before fabrication
- Secure data handling for record submission, prescription documentation, and device design files
AIOMEGA® technology is designed to support the clinician’s workflow — not replace clinical judgment. All diagnostic interpretation, treatment planning, and therapeutic decisions remain solely under clinician authority.
precision manufactuRING
AIOMEGA® Fabrication & Final Inspection
Fabrication
Each AIOMEGA® device is digitally designed and fabricated using a controlled CAD/CAM workflow. Clinician‑submitted records are translated into a precision digital model that preserves the intended mandibular relationship throughout the design process. The Vertical Flange, Protrusive Flange, and Mandibular Plateau geometries are maintained with strict dimensional tolerances to ensure predictable mandibular tracking. The digital design is converted into a production‑ready file and manufactured using high‑resolution additive or subtractive processes depending on the selected Material. The fabrication workflow is engineered to minimize distortion, maintain consistent thickness profiles, and ensure that the prescribed mandibular position is accurately reproduced in the Final device.
Final Inspection
Every device undergoes a structured, multi‑point quality inspection to verify dimensional accuracy, surface finish, and geometric fidelity. Critical features — including the Vertical Flange, Protrusive Flange, Mandibular Plateau, and overall thickness profiles — are checked against the digital prescription. This ensures that the delivered device matches the intended design specifications and maintains the engineered mandibular relationship selected by the clinician.
Materials, safety & handling
AIOMEGA® SMART® DIGITAL WORKFLOW: MATERIALS, SAFETY AND HANDLING
AIOMEGA® devices are fabricated using biocompatible, medical‑grade polymers selected for durability, dimensional stability, and intraoral comfort. All materials meet applicable ISO 10993 biocompatibility standards for mucosal contact. Material selection varies by device type and may include rigid SLA‑printed polymers or flexible thermo‑elastic components depending on the clinician’s prescription.
Each device is manufactured to the clinician’s prescribed mandibular and vertical settings. Prior to delivery, every appliance undergoes a final inspection to verify geometry, surface finish, and mechanical features. Clinicians should instruct patients on proper insertion, removal, cleaning, and storage to maintain device integrity and hygiene.
Scientific Design Architecture of AIOMEGA® Devices
Structural Components
Vertical Flange (VF)
The Vertical Flange establishes the device’s vertical dimension and guides the mandible along a defined inferior trajectory during voluntary mouth opening. It maintains consistent vertical separation and provides a stable interface for the Protrusive Flange.
Protrusive Flange (PF)
The Protrusive Flange interfaces with the Vertical Flange to guide the mandible along a controlled anteroposterior pathway. It defines the initial mandibular position and supports incremental anterior movement during mouth opening.
Mandibular Plateau (MP)
The Mandibular Plateau provides a smooth, contoured surface that stabilizes mandibular tracking. Its curvature supports lateral freedom of movement and maintains predictable mandibular orientation across dynamic movements.
Mandibular Positioning Framework
Resting Anterior Position (RAP)
RAP defines the baseline anteroposterior mandibular position when the device is fully seated. It establishes the starting point for the CONNECTED‑ARC‑OF‑MOTION®.
Resting Vertical Position (RVP)
RVP defines the baseline vertical separation between arches and is calculated as: RVP = MP + 2 × TCT This reflects the combined contribution of the Mandibular Plateau and the tooth‑covering thickness of both trays.
Tray Thickness (TCT)
TCT contributes directly to RVP and influences the inferior component of the mandibular pathway. It is a fabrication parameter.
Voluntary Mouth Opening (VMO)
VMO describes the degree of voluntary mouth opening performed while the device is worn. The AIOMEGA® design couples VMO to predictable anterior and inferior mandibular displacement through the VF–PF–MP interaction.
Multi‑Segment Airway narrowing in osa
Anatomical Regions of Airway Relevance
AIO Breathe® devices support a stable mandibular posture. Mandibular posture is clinically relevant to several anatomical regions of the upper airway, which are commonly evaluated when assessing multi‑segment narrowing in obstructive sleep apnea (OSA).
The following regions represent natural anatomical segments where narrowing may occur.
Key anatomical regions include:
- Nasopharynx — the uppermost airway segment behind the nasal cavity. Narrowing of the nasopharynx is commonly associated with mouth breathing. Obstruction of this area can increase inspiratory effort and contribute to downstream airway collapse due to negative pressure effects.
- Velopharynx — the region behind the soft palate, often evaluated for retropalatal narrowing.
- Palatoglossus Region — the area where the tongue base meets the soft palate.
- Oropharyngeal Space — the mid‑pharyngeal region located behind the tongue.
- Hyoid–Subglossal Region — the area beneath the tongue associated with the hyoid bone and suprahyoid musculature.
- Hyoid–Epiglottic Region — the space between the hyoid bone and the epiglottis.
- Hyoid–Sub‑Epiglottic Region — the area just below the epiglottis extending toward the hypopharynx.
These anatomical levels reflect the multi‑segment structure of the upper airway and provide context for clinicians when evaluating airway imaging or planning treatment.
This section describes anatomy only and does not imply device performance or mechanical effects.
using SMART‑Rx™ & AIO‑Rx™ Clinical Guidance System
Integrating Scientific Design with Clinical Workflow: SMART‑Rx™ + AIO‑Rx™
The AIOMEGA® Clinical Guidance System is a structured, clinician‑directed framework that supports the selection of a predictable, geometry‑aligned starting point for mandibular positioning. It does not automate decisions or replace clinician judgment. Instead, it provides high‑level guidance that aligns patient‑specific considerations with the engineered biomechanics of the AIOMEGA® device family.
What Is a Clinical Guidance System?
SMART‑Rx™ + AIO‑Rx™
A clinical guidance system is a structured set of tools that helps clinicians organize patient‑specific information and map it to device‑specific geometry. It does not diagnose, predict outcomes, or automate treatment decisions.
Instead, it provides:
- A consistent framework
- A reproducible starting point
- A geometry‑aligned prescription foundation
- A standardized approach across clinicians
SMART‑Rx™ and AIO‑Rx™ together form the AIOMEGA® Clinical Guidance System.
AIOMEGA® Clinical Guidance System
SMART‑Rx™ — Structured Mandibular Assessment
SMART‑Rx™ provides a structured framework for clinicians to consistently organize and interpret airway‑related findings — the clinician performs the evaluation, not the software. Built on the engineered biomechanics of the AIOMEGA® device family, SMART‑Rx™ incorporates:
- Resting Anterior Position (RAP)
- Resting Vertical Position (RVP)
- Tray Thickness (TCT)
- Voluntary Mouth Opening (VMO)
- Dentition and occlusal considerations
- Mandibular range of motion
- CBCT‑based anatomical observations
- Clinical history and tolerance factors
SMART‑Rx™ provides a structured, geometry‑aligned starting point for mandibular positioning. It supports — not replaces — clinician judgment.
AIO‑Rx™ — First‑Order Prescription Guidance
AIO‑Rx™ provides a structured framework that allows clinicians to convert the SMART‑Rx™ assessment into a prescription‑ready mandibular position aligned with the VF–PF–MP interaction and the CONNECTED‑ARC‑OF‑MOTION® geometry. It defines the key geometric elements clinicians reference when writing an AIO Breathe prescription:
- Initial protrusive position
- Initial vertical dimension
- Expected mandibular pathway during VMO
- Relationship between RAP, RVP, and device geometry
AIO‑Rx™ provides a clear, reproducible, geometry‑aligned starting prescription consistent with the device’s engineered biomechanics — supporting, not replacing, clinician judgment.
Integration: Scientific Design & clinical workflow
SMART‑Rx™ and AIO‑Rx™ - Built from Device Design
SMART‑Rx™ and AIO‑Rx™ are built directly on the engineering principles of the AIOMEGA® system, including:
- Vertical Flange (VF)
- Protrusive Flange (PF)
- Mandibular Plateau (MP)
- RAP, RVP, TCT, VMO
- CONNECTED‑ARC‑OF‑MOTION®
This ensures that the clinician’s starting point is:
- Biomechanically coherent
- Predictable
- Reproducible
- Aligned with device geometry
SMART‑Rx™ and AIO‑Rx™ - Built for Seamless Workflow
SMART‑Rx™ and AIO‑Rx™ integrate seamlessly into the AIOMEGA® workflow:
- Patient evaluation
- SMART‑Rx™ assessment
- AIO‑Rx™ first‑order prescription
- Device fabrication
- Optional CBCT or sleep‑study evaluation
- Follow‑up and refinement
This structure ensures every clinician begins with a consistent, geometry‑aligned starting point.
The internal logic, decision pathways, and computational rules used by SMART‑Rx™ and AIO‑Rx™ are proprietary and not disclosed; clinicians interact only with the high‑level guidance outputs. Upon request, clinicians may review the conceptual basis of the system as described in AIOMEGA’s issued patents, without revealing the proprietary internal algorithms.
Cases are accepted and processed through our secure AIO® Portal.
new to aiOMEGA®? join the AIO® portal, partner with us
To onboard the AIOMEGA® Portal and submit cases, please contact us through the Contact Us or Partner with Us page and provide:
- Ordering team member’s name
- Their E-Mail address
- Practice name
- Practice phone number
Our team will create your portal access and guide you through the onboarding process.
Clinicians can submit a digital scan and prescription to begin fabrication of an AIOMEGA® device at AIO PORTALS or SUBMIT A CASE (Above). AIOMEGA® builds devices based solely on the clinician’s anatomical and physiological assessment.
Copyright © 2026 AIOMEGA® LLC - All Rights Reserved.
AIOMEGA® — Advanced Intraoral Medical Devices
Information on this site does not replace professional medical advice.
Use of all devices must follow FDA-cleared labeling and clinician supervision.
Prescription-only medical devices. See FDA-cleared labeling for full safety information.
AIOMEGA® SLEEP 2026 - Booth #968
We’re excited to welcome you to SLEEP 2026 in Baltimore. Visit Booth #968 to meet the AIOMEGA® team and preview our latest clinical innovations.
Join us for three national poster presentations on June 15–16, featuring new research in:
- Adult OSA therapy
- Pediatric PDS outcomes
- Next‑generation digital workflows