BIOMERS TRANSLUCENT ORTHODONTIC BRACKET— 510(k) K101481

Name: FDA 510(k) clearance K101481
Creator: U.S. Food and Drug Administration
Published: 2010-06-23

Substantially Equivalent

Biomers Products, LLC

FDA 510(k) clearance K101481 for BIOMERS TRANSLUCENT ORTHODONTIC BRACKET, Substantially Equivalent on 2010-06-23. Applicant: Biomers Products, LLC. Device class: 2.

Clearance details

Applicant: Biomers Products, LLC
Product code: Code NJM
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2010-05-28
Decision date: 2010-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.