Cleared Traditional

K092251 - BIODENTINE
(FDA 510(k) Clearance)

K092251 · Septodont · Dental

Oct 2009

Decision

94d

Days

Class 2

Risk

K092251 is an FDA 510(k) clearance for the BIODENTINE. This device is classified as a Resin, Root Canal Filling (Class II — Special Controls, product code KIF).

Submitted by Septodont (Washington, US). The FDA issued a Cleared decision on October 30, 2009, 94 days after receiving the submission on July 28, 2009.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3820.

Submission Details

510(k) Number	K092251 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 28, 2009
Decision Date	October 30, 2009
Days to Decision	94 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement