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FDA 510(k)

Blue Sky Bio Computerized Orthodontic Bracket System

K-Number: K182338 · 2018-11-09

ApplicantBlue Sky Bio
Decision Date2018-11-09
Product CodeDYW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Blue Sky Bio Computerized Orthodontic Bracket System is a medical device manufactured by Blue Sky Bio. It received FDA 510(k) clearance on 2018-11-09 under approval number K182338. 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 Blue Sky Bio Computerized Orthodontic Bracket System?

Blue Sky Bio Computerized Orthodontic Bracket System is a medical device that received FDA 510(k) clearance on 2018-11-09. It is manufactured by Blue Sky Bio. The 510(k) number is K182338.

When was Blue Sky Bio Computerized Orthodontic Bracket System approved by the FDA?

Blue Sky Bio Computerized Orthodontic Bracket System received FDA 510(k) clearance on 2018-11-09, under approval number K182338.

What company makes Blue Sky Bio Computerized Orthodontic Bracket System?

Blue Sky Bio Computerized Orthodontic Bracket System is manufactured by Blue Sky Bio.

What is the FDA product code for Blue Sky Bio Computerized Orthodontic Bracket System?

The FDA product code for Blue Sky Bio Computerized Orthodontic Bracket System is DYW.

Related Clinical Trials

NCT07204925 Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1 RECRUITING NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT05006339 The Use of Remote Monitoring for Orthodontic Retention Review ACTIVE_NOT_RECRUITING NCT07291830 A Novel Remineralizing Self-Etch Primer for Orthodontic Bracket Bonding NOT_YET_RECRUITING NCT05905224 Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol COMPLETED NCT07318623 Comparative Outcomes of Damon Ultima vs Pitts 21 Pro Bracket Systems NOT_YET_RECRUITING

Other Devices by Blue Sky Bio

K163251Life Essence Universal Porcelain System

Related Devices (Code: DYW)

K160720Carriere Motion Clear Class IIOrtho Organizers, Inc. K150830CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew K150702Exceed TxGreat Lakes Orthodontics, Ltd. 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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