SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES— 510(k) K983242

Name: FDA 510(k) clearance K983242
Creator: U.S. Food and Drug Administration
Published: 1998-12-11

Substantially Equivalent

Sirona Dental Systems GmbH

FDA 510(k) clearance K983242 for SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES, Substantially Equivalent on 1998-12-11. 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: 1998-09-16
Decision date: 1998-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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