Cleared Traditional

Biodentine XP 500, Biodentine XP 200

K211799 · Septodont · Dental
Aug 2021
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K211799 is an FDA 510(k) clearance for the Biodentine XP 500, Biodentine XP 200, a Resin, Root Canal Filling (Class II — Special Controls, product code KIF), submitted by Septodont (Saint-Maur Des Fosses Cedex, FR). The FDA issued a Cleared decision on August 10, 2021, 61 days after receiving the submission on June 10, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number K211799 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2021
Decision Date August 10, 2021
Days to Decision 61 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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