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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 a medical device manufactured by Oracrew. It received FDA 510(k) clearance on 2016-08-26 under approval 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. It is manufactured by Oracrew. The 510(k) number is K150830.

When was CompleClear Plastic Orthodontic Bracket and Wire Appliance approved by the FDA?

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

What company makes CompleClear Plastic Orthodontic Bracket and Wire Appliance?

CompleClear Plastic Orthodontic Bracket and Wire Appliance is manufactured by Oracrew.

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

NCT07610603 Cleaning Methods for Clear Aligners COMPLETED NCT06308640 Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography ACTIVE_NOT_RECRUITING NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT07039071 Evaluation of Clinical and Patient-Reported Outcomes of Laceback RECRUITING NCT07291830 A Novel Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding NOT_YET_RECRUITING NCT07318623 Comparative Outcomes of Damon Ultima vs Pitts 21 Pro Bracket Systems NOT_YET_RECRUITING

Related Devices (Code: DYW)

K160720Carriere Motion Clear Class IIOrtho Organizers, Inc. K150702Exceed TxGreat Lakes Orthodontics, Ltd. K182338Blue Sky Bio Computerized Orthodontic Bracket SystemBlue Sky Bio K180718ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIESTomy, Inc. K201940Braces on Demand BracketBraces on Demand, Inc. K252760Carriere® Motion Pro® Clear Bite CorrectorOrtho 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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