FDA 510(k)

Blue Sky Bio Zygomatic Implant System

Número K: K190491 · 2019-08-12

Data da decisão2019-08-12

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Blue Sky Bio Zygomatic Implant System 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 2019-08-12 under 510(k) number K190491. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Blue Sky Bio Zygomatic Implant System?

Blue Sky Bio Zygomatic Implant System is a medical device that received FDA 510(k) clearance on 2019-08-12. The listed applicant is Blue Sky Bio, LLC. The 510(k) number is K190491.

When did Blue Sky Bio Zygomatic Implant System receive FDA 510(k) clearance?

Blue Sky Bio Zygomatic Implant System received FDA 510(k) clearance on 2019-08-12, under 510(k) number K190491.

Who is the listed applicant for Blue Sky Bio Zygomatic Implant System?

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 Zygomatic Implant System?

The FDA product code for Blue Sky Bio Zygomatic Implant System is NHA.

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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 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 K180107Blue Sky Bio Aligner

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Fonte oficial

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