COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE— 510(k) K080677

Name: FDA 510(k) clearance K080677
Creator: U.S. Food and Drug Administration
Published: 2008-06-06

Substantially Equivalent

Kaltenbach & Voigt GmbH & Co.

FDA 510(k) clearance K080677 for COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE, Substantially Equivalent on 2008-06-06. Applicant: Kaltenbach & Voigt GmbH & Co.. Device class: 1.

Clearance details

Applicant: Kaltenbach & Voigt GmbH & Co.
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2008-03-10
Decision date: 2008-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

Download summary PDF View on FDA.gov ↗

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