FDA 510(k)

Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX

Número K: K232653 · 2024-04-03

Data da decisão2024-04-03

Código do produtoNXC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX 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 2024-04-03 under 510(k) number K232653. 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 Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX?

Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX is a medical device that received FDA 510(k) clearance on 2024-04-03. The listed applicant is Blue Sky Bio, LLC. The 510(k) number is K232653.

When did Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX receive FDA 510(k) clearance?

Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX received FDA 510(k) clearance on 2024-04-03, under 510(k) number K232653.

Who is the listed applicant for Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX?

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 Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX?

The FDA product code for Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX is NXC.

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

K221845Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G 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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Fonte oficial

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