Cleared Traditional

ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES

K080556 · Merz Dental GmbH · Dental
May 2008
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K080556 is an FDA 510(k) clearance for the ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Merz Dental GmbH (Albuquerque, US). The FDA issued a Cleared decision on May 2, 2008, 64 days after receiving the submission on February 28, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K080556 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2008
Decision Date May 02, 2008
Days to Decision 64 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBG — Crown And Bridge, Temporary, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3770

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