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FDA 510(k)

CompleClear Plastic Orthodontic Bracket and Wire Appliance

K-Number: K150830 · 2016-08-26

ApplicantOracrew
Decision Date2016-08-26
Product CodeDYW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CompleClear Plastic Orthodontic Bracket and Wire Appliance is the device name listed in this FDA 510(k) record. The listed applicant is Oracrew. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K150830. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CompleClear Plastic Orthodontic Bracket and Wire Appliance?

CompleClear Plastic Orthodontic Bracket and Wire Appliance is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Oracrew. The 510(k) number is K150830.

When did CompleClear Plastic Orthodontic Bracket and Wire Appliance receive FDA 510(k) clearance?

CompleClear Plastic Orthodontic Bracket and Wire Appliance received FDA 510(k) clearance on 2016-08-26, under 510(k) number K150830.

Who is the listed applicant for CompleClear Plastic Orthodontic Bracket and Wire Appliance?

The FDA 510(k) record lists Oracrew as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CompleClear Plastic Orthodontic Bracket and Wire Appliance?

The FDA product code for CompleClear Plastic Orthodontic Bracket and Wire Appliance is DYW.

Related Clinical Trials

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Related Devices (Code: DYW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252760Carriere® Motion Pro® Clear Bite CorrectorOrtho Organizers, Inc.K251196Composite Orthodontic Brackets and ButtonsEc Certification Service GmbHK201940Braces on Demand BracketBraces on Demand, Inc.K182338Blue Sky Bio Computerized Orthodontic Bracket SystemBlue Sky BioK180718ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIESTomy, Inc.K160720Carriere Motion Clear Class IIOrtho Organizers, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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