BioHPP - breCAM.BioHPP— 510(k) K152113

Substantially Equivalent

Bredent GmbH & Co. KG

FDA 510(k) clearance K152113 for BioHPP - breCAM.BioHPP, Substantially Equivalent on 2016-07-21. Applicant: Bredent GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Bredent GmbH & Co. KG
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2015-07-29
Decision date: 2016-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Senden, 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.