ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD— 510(k) K013650

Name: FDA 510(k) clearance K013650
Creator: U.S. Food and Drug Administration
Published: 2001-12-06

Substantially Equivalent

Sirona Dental Systems GmbH

FDA 510(k) clearance K013650 for ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD, Substantially Equivalent on 2001-12-06. Applicant: Sirona Dental Systems GmbH. Device class: 2.

Clearance details

Applicant: Sirona Dental Systems GmbH
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2001-11-06
Decision date: 2001-12-06
Decision: Substantially Equivalent
Clearance type: Special
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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