SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE— 510(k) K110796

Name: FDA 510(k) clearance K110796
Creator: U.S. Food and Drug Administration
Published: 2011-03-31

Substantially Equivalent

Biomers Products, LLC

FDA 510(k) clearance K110796 for SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE, Substantially Equivalent on 2011-03-31. Applicant: Biomers Products, LLC. Device class: 2.

Clearance details

Applicant: Biomers Products, LLC
Product code: Code DYW
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2011-03-22
Decision date: 2011-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, Bc, CA

Download summary PDF View on FDA.gov ↗

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