AIOMEGA® AIO Breathe® Series

  AIOMEGA® devices are custom, prescription‑only intraoral medical devices fabricated according to the records and specifications provided by licensed clinicians. Each device is individually designed to support clinician‑directed mandibular positioning within the parameters selected during the prescription process. All diagnostic decisions, treatment planning, and follow‑up care remain solely under the authority of the prescribing clinician. 

Every AIOMEGA® device is fabricated from patient‑specific records submitted by the clinician. These may include intraoral scans or impressions, bite registrations, the prescribed mandibular position, vertical dimension specifications, and any additional clinical instructions. These clinician‑submitted records form the foundation of the device’s digital design and guide the fabrication process from start to finish. 

Dual‑Arch Construction  

The device includes upper and lower components designed to maintain the mandible in the position prescribed by the clinician.

Defined Vertical Dimension 

The vertical separation between arches is determined by the clinician and incorporated directly into the device design.

Guided or Controlled Motion Components  

The device geometry may include features that limit or direct mandibular movement within the design’s mechanical range.

Required Note:   These descriptions reflect mechanical design only and do not imply clinical performance or therapeutic effect.

AIOMEGA® devices are fabricated using precision‑SLA printing, a digital additive manufacturing process that supports consistent fit, structural integrity, and reproducibility. The digital design generated from clinician‑submitted records is translated directly into the printing workflow, allowing fine‑scale geometric detail to be produced with high accuracy. Quality checks are performed throughout fabrication to help ensure that the final device aligns with the clinician’s prescribed mandibular position, vertical dimension, and submitted records. 

AIOMEGA® devices are fabricated using FDA‑cleared, biocompatible materials suitable for long‑term intraoral use. These materials meet ISO‑10993 biocompatibility standards, including evaluations for cytotoxicity, sensitization, irritation, genotoxicity, and systemic toxicity.

Manufacturers of these materials also perform additional testing such as mechanical durability validation, chemical stability assessments, intraoral wear and fracture‑resistance testing, and long‑term aging and environmental exposure evaluations. These certifications support the safe use of the materials when the device is used as directed by a licensed clinician.

Clinicians determine whether an AIOMEGA® device is appropriate for a given patient, the mandibular position used for fabrication, the vertical dimension, and any adjustments made during fitting. The follow‑up schedule, evaluation of comfort and fit, and any modifications to therapy remain solely under the authority of the prescribing clinician. Patients should contact their clinician with any questions regarding comfort, fit, or use. 

Each AIOMEGA® device is accompanied by official Instructions for Use (IFU) that include indications, contraindications, warnings, precautions, and care and handling information. Patients should follow the IFU and all clinician‑provided guidance.

Labeling Notice:   

Indications, contraindications, warnings, and precautions are provided in the device’s FDA‑cleared labeling and Instructions for Use.