Clearance Summary
WILDE AUXILIARIES received FDA 510(k) clearance under submission number K912991, 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 1991-12-19.
- Submission: K912991
- Applicant / Sponsor: Wilde-USA, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3760
- Decision date: 1991-12-19
Classification & Regulation
This clearance is catalogued under FDA product code EBI and 21 CFR 872.3760, within the Dental review panel as a Class II device.