Cleared Traditional

CUTTERSIL ACTIVATOR UNIVERSAL PLUS

K080338 · Heraeus Kulzer,GmbH · Dental
Apr 2008
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K080338 is an FDA 510(k) clearance for the CUTTERSIL ACTIVATOR UNIVERSAL PLUS, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Heraeus Kulzer,GmbH (South Bend, US). The FDA issued a Cleared decision on April 21, 2008, 74 days after receiving the submission on February 7, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K080338 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 2008
Decision Date April 21, 2008
Days to Decision 74 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELW — Material, Impression
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3660

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