SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES— 510(k) K032543

Name: FDA 510(k) clearance K032543
Creator: U.S. Food and Drug Administration
Published: 2003-11-14

Substantially Equivalent

Sirona Dental Systems GmbH

FDA 510(k) clearance K032543 for SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES, Substantially Equivalent on 2003-11-14. Applicant: Sirona Dental Systems GmbH. Device class: 1.

Clearance details

Applicant: Sirona Dental Systems GmbH
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2003-08-18
Decision date: 2003-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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