Clearance Summary
KERAMAIL received FDA 510(k) clearance under submission number K915653, sponsored by Wilde-USA, 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 1993-04-08.
- Submission: K915653
- Applicant / Sponsor: Wilde-USA, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.6660
- Decision date: 1993-04-08
Classification & Regulation
This clearance is catalogued under FDA product code EIH and 21 CFR 872.6660, within the Dental review panel as a Class II device.