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FDA 510(k)

Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G

K-Number: K221845 · 2023-02-24

ApplicantBlue Sky Bio, LLC
Decision Date2023-02-24
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G is the device name listed in this FDA 510(k) record. The listed applicant is Blue Sky Bio, LLC. It received FDA 510(k) clearance on 2023-02-24 under 510(k) number K221845. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G?

Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G is a medical device that received FDA 510(k) clearance on 2023-02-24. The listed applicant is Blue Sky Bio, LLC. The 510(k) number is K221845.

When did Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G receive FDA 510(k) clearance?

Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G received FDA 510(k) clearance on 2023-02-24, under 510(k) number K221845.

Who is the listed applicant for Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G?

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

What is the FDA product code for Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G?

The FDA product code for Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G is NXC.

Related Clinical Trials

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Other records listing Blue Sky Bio, LLC 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 FLXK212785Blue 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 SystemK182338Blue Sky Bio Computerized Orthodontic Bracket System

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Related Devices (Code: NXC)

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.

K260527FACE4D AlignerAvinent Implant System S.L.U.K260788Smylio AlignersSmylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile SystemDror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) LimitedK250739Primeprint Direct AlignerDreve Dentamid GmbH

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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