Cleared Traditional

CEREC SpeedGlaze

K160099 · Sirona Dental Systems GmbH · Dental
Jun 2016
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K160099 is an FDA 510(k) clearance for the CEREC SpeedGlaze, 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 June 2, 2016, 135 days after receiving the submission on January 19, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K160099 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2016
Decision Date June 02, 2016
Days to Decision 135 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EIH — Powder, Porcelain
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6660

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