EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS— 510(k) K131197

Name: FDA 510(k) clearance K131197
Creator: U.S. Food and Drug Administration
Published: 2013-08-27

Substantially Equivalent

Dental Morelli

FDA 510(k) clearance K131197 for EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS, Substantially Equivalent on 2013-08-27. Applicant: Dental Morelli. Device class: 2.

Clearance details

Applicant: Dental Morelli
Product code: Code NJM
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2013-04-26
Decision date: 2013-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aventura, FL, US

Download summary PDF View on FDA.gov ↗

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