BIOMERS TRANSLUCENT ORTHODONTIC WIRE— 510(k) K081143

Name: FDA 510(k) clearance K081143
Creator: U.S. Food and Drug Administration
Published: 2008-05-02

Substantially Equivalent

Biomers Product, LLC

FDA 510(k) clearance K081143 for BIOMERS TRANSLUCENT ORTHODONTIC WIRE, Substantially Equivalent on 2008-05-02. Applicant: Biomers Product, LLC. Device class: 2.

Clearance details

Applicant: Biomers Product, LLC
Product code: Code DYW
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2008-04-22
Decision date: 2008-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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