FDA 510(k)

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

Número K: K221845 · 2023-02-24

Data da decisão2023-02-24

Código do produtoNXC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Blue Sky Bio, LLC como candidato(a)

K232653Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments K202026Blue Sky Bio CAD-CAM Abutments K201919Blue Sky Bio TAD K190491Blue Sky Bio Zygomatic Implant System K180107Blue Sky Bio Aligner

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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) Limited K250739Primeprint Direct AlignerDreve Dentamid GmbH

Fonte oficial

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