Clearance Summary
The AVEOtsd (Tongue Stabilizing Device) Mouthpiece received FDA 510(k) clearance under submission number K231663, sponsored by Innovative Health Technologies (Nz), Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2023-09-18.
- Submission: K231663
- Applicant / Sponsor: Innovative Health Technologies (Nz), Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2023-09-18
Classification & Regulation
This clearance is catalogued under FDA product code LRK and 21 CFR 872.5570, within the Dental review panel as a Class II device.