BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P— 510(k) K101064

Name: FDA 510(k) clearance K101064
Creator: U.S. Food and Drug Administration
Published: 2010-09-14

Substantially Equivalent

Bredent GmbH & Co. KG

FDA 510(k) clearance K101064 for BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P, Substantially Equivalent on 2010-09-14. Applicant: Bredent GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Bredent GmbH & Co. KG
Product code: Code ELM
Device class: Class 2
Regulation: 21 CFR 872.3590
Advisory panel: Dental
Date received: 2010-04-16
Decision date: 2010-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, Baden Wurttemberg, DE

Download summary PDF View on FDA.gov ↗

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