Oniris - Oniris

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Oniris Plus

Device Name

Oniris

Model / Reference

ONIPLUSSPT2, ONIPLUSIO - ONIPLUSIE, ONIPLUS, ONIPLUSIET2, ONIPLUSIET1

Primary DI / UDI-DI

03665389000286, 03665389000262, 03665389000248, 03665389000385, 03665389000378

Basic UDI-DI

3665389ONIRIS8X

510(k) Number

K250353 ↗

FDA Product Code

LRK

EMDN Code

Q03010299 Antisnoring and obstructive sleep apnoea devices - other

Models / Variants

Oniris

Oniris Plus

Device Class

Class I EUDAMED

Class II 510(k)

Regulation

21 CFR Part 872.5570

EU market of registration

France

Ireland

Bulgaria

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Are the Oniris and Oniris Plus devices reusable or designed for single-use only? Why does this matter for patients or clinicians?

  The Oniris and Oniris Plus are explicitly designed for single-use only. This is important because single-use devices reduce the risk of cross-contamination and infection, ensuring hygiene and safety for each patient. Since they are thermoformable and intended for home use or dental professional supervision, they are not meant to be reused, even after cleaning or sterilization.

• What key differences exist between the Oniris and Oniris Plus models, particularly in terms of functionality and patient comfort?

  The Oniris Plus features two key enhancements over the classic Oniris: enhanced bruxism resistance (better suited for patients who grind their teeth) and 30% greater intraoral volume, which may provide a more comfortable fit and potentially better airway support. The classic Oniris is designed for general snoring and mild obstructive sleep apnea, while the Plus model caters to patients needing additional stability and space.

• How should the Oniris devices be stored before use, and what precautions should be taken to maintain their sterility?

  The Oniris and Oniris Plus are supplied in sterile packaging, meaning they should remain unopened until ready for use. Storage should follow the manufacturer’s guidelines to preserve sterility—typically in a clean, dry environment away from direct sunlight or extreme temperatures. Once opened, the device should be used immediately, as single-use devices are not intended for later use or reprocessing.

• What regulatory pathways have the Oniris and Oniris Plus followed, and how does this affect their availability or approval status?

  The Oniris and Oniris Plus have been authorized through FDA 510K clearance and MDR (Medical Device Regulation) compliance, confirming they meet Class II medical device standards under the Dental specialty category. This regulatory route ensures they are classified as Anti-Snoring Devices (FDA code 872.5570) and are legally marketable in the U.S. and EU, though the exact availability depends on local regulatory approvals and distribution agreements.