Clearance Summary
TONGUE SCRAPER received FDA 510(k) clearance under submission number K942076, sponsored by Maharishi Ayur-Ved. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1994-08-23.
- Submission: K942076
- Applicant / Sponsor: Maharishi Ayur-Ved
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 1994-08-23
Classification & Regulation
This clearance is catalogued under FDA product code LCN and 21 CFR 872.6855, within the Dental review panel as a Class I device.