Cleared Traditional

K123952 - CEREC BLOCS C IN
(FDA 510(k) Clearance)

K123952 · Sirona Dental Systems GmbH · Dental

Mar 2013

Decision

89d

Days

Class 2

Risk

K123952 is an FDA 510(k) clearance for the CEREC BLOCS C IN. This device is classified as a Powder, Porcelain (Class II — Special Controls, product code EIH).

Submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on March 20, 2013, 89 days after receiving the submission on December 21, 2012.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K123952 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2012
Decision Date	March 20, 2013
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF