CompleClear Plastic Orthodontic Bracket and Wire Appliance— 510(k) K150830

Name: FDA 510(k) clearance K150830
Creator: U.S. Food and Drug Administration
Published: 2016-08-26

Substantially Equivalent

Oracrew

FDA 510(k) clearance K150830 for CompleClear Plastic Orthodontic Bracket and Wire Appliance, Substantially Equivalent on 2016-08-26. Applicant: Oracrew. Device class: 2.

Clearance details

Applicant: Oracrew
Product code: Code DYW
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2015-03-30
Decision date: 2016-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, 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.