AGC CEM— 510(k) K030168

Substantially Equivalent

Wieland Dental + Technik GmbH & Co. KG

FDA 510(k) clearance K030168 for AGC CEM, Substantially Equivalent on 2003-03-21. Applicant: Wieland Dental + Technik GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Wieland Dental + Technik GmbH & Co. KG
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2003-01-17
Decision date: 2003-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pforzheim, 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.