Clearance Summary
DR. B'S MOUTHPIECE, MODEL 32129-10002 received FDA 510(k) clearance under submission number K991948, sponsored by Snore - Ezzer. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1999-09-02.
- Submission: K991948
- Applicant / Sponsor: Snore - Ezzer
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 1999-09-02
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.