Identifiers
- 510(k) Number
- K190236 FDA 510(k)
- FDA Product Code
- LRK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.5570 FDA 510(k)
- Regulation Number
- 872.5570 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The O2Vent Optima is a dental device classified as an anti-snoring device. It is designed to help alleviate snoring by improving airflow during sleep.
The device is supplied as a single-use product and is regulated under FDA 510K clearance. It is available in various sizes and is intended for dental use, though specific storage requirements are not detailed in the provided information.
Frequently asked questions
What is the O2Vent Optima device used for?
The O2Vent Optima is a dental device specifically designed to help alleviate snoring by improving airflow during sleep. It is classified as an anti-snoring device and is intended for dental use.
Is the O2Vent Optima a single-use or reusable device?
The O2Vent Optima is supplied as a single-use product. This means it is designed to be used once and then replaced, ensuring optimal hygiene and performance for each use.
What sizes are available for the O2Vent Optima?
The O2Vent Optima is available in various sizes to accommodate different anatomical needs. However, specific size details are not provided in the available information.
What is the regulatory status of the O2Vent Optima?
The O2Vent Optima is regulated under FDA 510K clearance, which means it has been determined to be substantially equivalent to other legally marketed devices of the same type.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190236 | Class II | Active |
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Manufacturer
- Manufacturer
- Oventus Manufacturing Pty, Ltd.
Sources (1)
- FDA 510(k) K190236 24 fields · synced Sep 23, 2026