Clearance Summary
PLANUSTAR AND DENS NOBILIS DENTURE TEETH received FDA 510(k) clearance under submission number K912989, 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 1991-08-16.
- Submission: K912989
- Applicant / Sponsor: Wilde-USA, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1991-08-16
Classification & Regulation
This clearance is catalogued under FDA product code EMI and 21 CFR 872.4565, within the Dental review panel as a Class I device.