Clearance Summary
POLYCARBOXYLATE (PCA) CEMENT received FDA 510(k) clearance under submission number K010240, sponsored by Rite-Dent Manufacturing Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2001-03-27.
- Submission: K010240
- Applicant / Sponsor: Rite-Dent Manufacturing Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2001-03-27
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.