Clearance Summary
DENTOLOCK received FDA 510(k) clearance under submission number K921071, sponsored by Dentmed , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1992-03-26.
- Submission: K921071
- Applicant / Sponsor: Dentmed , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5090
- Decision date: 1992-03-26
Classification & Regulation
This clearance is catalogued under FDA product code KOB and 21 CFR 876.5090, within the Gastroenterology, Urology review panel as a Class II device.