Clearance Summary
KERALLOY NON-GAMMA 2 AMALGAM received FDA 510(k) clearance under submission number K912992, 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 1991-11-13.
- Submission: K912992
- Applicant / Sponsor: Wilde-USA, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3070
- Decision date: 1991-11-13
Classification & Regulation
This clearance is catalogued under FDA product code EJJ and 21 CFR 872.3070, within the Dental review panel as a Class II device.