Clearance Summary
PERMAGUM PUTTY SOFT & PERMAGUM GARRANT received FDA 510(k) clearance under submission number K890449, sponsored by Wacker-Chemie GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1989-07-27.
- Submission: K890449
- Applicant / Sponsor: Wacker-Chemie GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 1989-07-27
Classification & Regulation
This clearance is catalogued under FDA product code ELW and 21 CFR 872.3660, within the Dental review panel as a Class II device.