FASTBRACES CERAMIC BRACKETS— 510(k) K130446

Name: FDA 510(k) clearance K130446
Creator: U.S. Food and Drug Administration
Published: 2013-06-07

Substantially Equivalent

Orthodontic Design and Production, Inc.

FDA 510(k) clearance K130446 for FASTBRACES CERAMIC BRACKETS, Substantially Equivalent on 2013-06-07. Applicant: Orthodontic Design and Production, Inc.. Device class: 2.

Clearance details

Applicant: Orthodontic Design and Production, Inc.
Product code: Code NJM
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2013-02-21
Decision date: 2013-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, CA, US

Download summary PDF View on FDA.gov ↗

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