Clearance Summary
SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT received FDA 510(k) clearance under submission number K931857, sponsored by Confi-Dental Products Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1993-07-22.
- Submission: K931857
- Applicant / Sponsor: Confi-Dental Products Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3765
- Decision date: 1993-07-22
Classification & Regulation
This clearance is catalogued under FDA product code EBC and 21 CFR 872.3765, within the Dental review panel as a Class II device.