Cleared Traditional

CEREC OPTI SPRAY

K080882 · Sirona Dental Systems GmbH · Dental
Apr 2008
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K080882 is an FDA 510(k) clearance for the CEREC OPTI SPRAY, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on April 11, 2008, 11 days after receiving the submission on March 31, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K080882 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2008
Decision Date April 11, 2008
Days to Decision 11 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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

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