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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 the device name listed in this FDA 510(k) record. The listed applicant is Blue Sky Bio. It received FDA 510(k) clearance on 2018-11-09 under 510(k) 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. The listed applicant is Blue Sky Bio. The 510(k) number is K182338.

When did Blue Sky Bio Computerized Orthodontic Bracket System receive FDA 510(k) clearance?

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

Who is the listed applicant for Blue Sky Bio Computerized Orthodontic Bracket System?

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

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.

Other records listing Blue Sky Bio as applicant

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.

K232653Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLXK221845Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner GK212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutmentsK202026Blue Sky Bio CAD-CAM AbutmentsK201919Blue Sky Bio TADK190491Blue Sky Bio Zygomatic Implant System

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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.K180718ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIESTomy, Inc.K160720Carriere Motion Clear Class IIOrtho Organizers, Inc.K150830CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew

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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