W&H Implantmed SI-1015 incl. Accessories— 510(k) K161957

Name: FDA 510(k) clearance K161957
Creator: U.S. Food and Drug Administration
Published: 2016-11-23

Substantially Equivalent

W&H Dentalwerk Burmoos GmbH

FDA 510(k) clearance K161957 for W&H Implantmed SI-1015 incl. Accessories, Substantially Equivalent on 2016-11-23. Applicant: W&H Dentalwerk Burmoos GmbH. Device class: 1.

Clearance details

Applicant: W&H Dentalwerk Burmoos GmbH
Product code: Code EBW
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2016-07-18
Decision date: 2016-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buermoos, AT

Download summary PDF View on FDA.gov ↗

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