PEEK Biosolution— 510(k) K173124

Substantially Equivalent

Merz Dental GmbH

FDA 510(k) clearance K173124 for PEEK Biosolution, Substantially Equivalent on 2017-12-18. Applicant: Merz Dental GmbH. Device class: 2.

Clearance details

Applicant: Merz Dental GmbH
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2017-09-29
Decision date: 2017-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lutjenburg, 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.