Clearance Summary
MULTI-PRIME AKA/MONO-PRIME received FDA 510(k) clearance under submission number K953476, sponsored by Silicon-Und Composite Spezialitaten 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 1995-09-22.
- Submission: K953476
- Applicant / Sponsor: Silicon-Und Composite Spezialitaten GmbH
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3200
- Decision date: 1995-09-22
Classification & Regulation
This clearance is catalogued under FDA product code KLE and 21 CFR 872.3200, within the Dental review panel as a Class II device.