AIOMEGA® AIO BREATHE®: FDA CLEARED FOR PEDIATRIC & ADULT OBSTRUCTIVE SLEEP APNEA
AIOMEGA® AIO BREATHE®: FDA CLEARED FOR PEDIATRIC & ADULT OBSTRUCTIVE SLEEP APNEA
“Our devices are designed using digital workflows and precision manufacturing. CBCT and other imaging modalities may be used by clinicians to understand craniofacial and airway-related anatomy. Any images shown on this site are illustrative and not evidence of clinical change.”
Clinicians may use imaging — when appropriate — to understand craniofacial and airway-related anatomy. AIOMD does not interpret imaging or provide diagnostic services.
Imaging can play an important role in helping clinicians understand craniofacial and airway‑related anatomy. When used as part of a clinician’s evaluation, imaging provides anatomical visualization that helps clarify spatial relationships among structures relevant to oral appliance therapy. These visual references may assist clinicians in assessing craniofacial features, dental relationships, and other anatomical considerations they deem relevant when determining whether a prescription oral device is appropriate. All interpretation, diagnostic decisions, and treatment planning remain solely under the authority of the prescribing clinician.
CBCT‑style images shown on this website are used only to illustrate anatomical structures, spatial relationships, or examples of device positioning. These images are illustrative, not patient‑specific, and are not intended to demonstrate clinical change, therapeutic effect, or treatment outcome. They are provided solely for general anatomical reference and device‑positioning examples.
Required Note: AIOMEGA® does not interpret imaging or provide diagnostic services.
AIOMEGA® devices are fabricated using a fully digital workflow designed to support accuracy, consistency, and reproducibility. The fabrication process begins with the clinician’s submitted records, which may include intraoral scans or impressions, bite registrations, the prescribed mandibular position, and the selected vertical dimension. These records form the foundation of the device’s digital design.
Once the clinician’s records are received, AIOMEGA® engineers construct a detailed digital model of the upper and lower arches. The prescribed mandibular position and vertical dimension are integrated directly into this model, ensuring that the device reflects the clinician’s specifications. The digital workflow allows for precise control of geometry, alignment, and structural features, supporting a consistent fabrication process from case to case.
This digital design is then translated into a precision‑SLA printing workflow, which supports the creation of custom intraoral devices with consistent fit and structural integrity. Throughout the process, quality checks are performed to help ensure that the final device aligns with the clinician’s submitted records and prescription parameters.
AIOMEGA®’s engineering process incorporates CAD/CAM methodologies to translate clinician‑submitted records into a custom device design.
This includes digital modeling of the upper and lower arches, integration of the clinician‑selected mandibular position, incorporation of the prescribed vertical dimension, and the creation of guided or interlocking motion pathways based on the device’s geometry.
These engineering steps ensure that each device is fabricated according to the clinician’s prescription and within the mechanical parameters of the design.
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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.

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: