CEREC SpeedGlaze— 510(k) K160099

Substantially Equivalent

Sirona Dental Systems GmbH

FDA 510(k) clearance K160099 for CEREC SpeedGlaze, Substantially Equivalent on 2016-06-02. Applicant: Sirona Dental Systems GmbH. Device class: 2.

Clearance details

Applicant: Sirona Dental Systems GmbH
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2016-01-19
Decision date: 2016-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bensheim, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.