Clearance Summary
PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT received FDA 510(k) clearance under submission number K112574, sponsored by Prime Dental Manufacturing, 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 2012-01-23.
- Submission: K112574
- Applicant / Sponsor: Prime Dental Manufacturing, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2012-01-23
Classification & Regulation
This clearance is catalogued under FDA product code EMA and 21 CFR 872.3275, within the Dental review panel as a Class II device.