AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS— 510(k) K113334

Name: FDA 510(k) clearance K113334
Creator: U.S. Food and Drug Administration
Published: 2012-02-03

Substantially Equivalent

Opal Orthodontics by Ultradent Products, Inc.

FDA 510(k) clearance K113334 for AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS, Substantially Equivalent on 2012-02-03. Applicant: Opal Orthodontics by Ultradent Products, Inc.. Device class: 2.

Clearance details

Applicant: Opal Orthodontics by Ultradent Products, Inc.
Product code: Code NJM
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2011-11-14
Decision date: 2012-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

Download summary PDF View on FDA.gov ↗

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