BIODENTINE

Resin, Root Canal Filling

SEPTODONT

The following data is part of a premarket notification filed by Septodont with the FDA for Biodentine.

Pre-market Notification Details

• Device ID: K140132
• 510k Number: K140132
• Device Name: BIODENTINE
• Classification: Resin, Root Canal Filling
• Applicant: SEPTODONT 416 S. TAYLOR AVE. Louisville, CO 80027
• Contact: Cora Bracho-troconis
• Correspondent: Cora Bracho-troconis; SEPTODONT 416 S. TAYLOR AVE. Louisville, CO 80027
• Product Code: KIF
• CFR Regulation Number: 872.3820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-01-17
• Decision Date: 2014-06-27