Clearance Summary
GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE received FDA 510(k) clearance under submission number K101540, sponsored by Novocol Inc. Dba Septodont and Confi-Dental Produc. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2010-10-29.
- Submission: K101540
- Applicant / Sponsor: Novocol Inc. Dba Septodont and Confi-Dental Produc
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 2010-10-29
Classification & Regulation
This clearance is catalogued under FDA product code EBF and 21 CFR 872.3690, within the Dental review panel as a Class II device.