Cleared Traditional

BIODENTINE

K140132 · Septodont · Dental
Jun 2014
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K140132 is an FDA 510(k) clearance for the BIODENTINE, a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by Septodont (Louisville, US). The FDA issued a Cleared decision on June 27, 2014, 161 days after receiving the submission on January 17, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K140132 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 2014
Decision Date June 27, 2014
Days to Decision 161 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code KIF — Resin, Root Canal Filling
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3820