Clearance Summary
ZOLLER BURNED LIP CONFORMER received FDA 510(k) clearance under submission number K832366, sponsored by Universal Prosthetics, 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 1983-09-26.
- Submission: K832366
- Applicant / Sponsor: Universal Prosthetics, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1983-09-26
Classification & Regulation
This clearance is catalogued under FDA product code EIG and 21 CFR 872.4565, within the Dental review panel as a Class I device.