SMARTmatic— 510(k) K163239

Substantially Equivalent

Kaltenbach & Voigt GmbH

FDA 510(k) clearance K163239 for SMARTmatic, Substantially Equivalent on 2017-03-17. Applicant: Kaltenbach & Voigt GmbH. Device class: 1.

Clearance details

Applicant: Kaltenbach & Voigt GmbH
Product code: Code EFA
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2016-11-18
Decision date: 2017-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Biberach, 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.