Cleared Traditional

K061809 - ARTEGRAL IMCROWN
(FDA 510(k) Clearance)

K061809 · Merz Dental GmbH · Dental

Sep 2006

Decision

78d

Days

Class 2

Risk

K061809 is an FDA 510(k) clearance for the ARTEGRAL IMCROWN, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Merz Dental GmbH (Tucker, US). The FDA issued a Cleared decision on September 13, 2006, 78 days after receiving the submission on June 27, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number	K061809 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 27, 2006
Decision Date	September 13, 2006
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF