Clearance Summary
SNORE-CURE ANTI-SNORING APPLIANCE received FDA 510(k) clearance under submission number K980952, sponsored by ORTHO-TAIN, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1998-06-01.
- Submission: K980952
- Applicant / Sponsor: ORTHO-TAIN, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 1998-06-01
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.