FDA 510(k)

Blue Sky Bio CAD-CAM Abutments

Número K: K202026 · 2020-12-18

Data da decisão2020-12-18

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Blue Sky Bio CAD-CAM Abutments 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 2020-12-18 under 510(k) number K202026. 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 CAD-CAM Abutments?

Blue Sky Bio CAD-CAM Abutments is a medical device that received FDA 510(k) clearance on 2020-12-18. The listed applicant is Blue Sky Bio, LLC. The 510(k) number is K202026.

When did Blue Sky Bio CAD-CAM Abutments receive FDA 510(k) clearance?

Blue Sky Bio CAD-CAM Abutments received FDA 510(k) clearance on 2020-12-18, under 510(k) number K202026.

Who is the listed applicant for Blue Sky Bio CAD-CAM Abutments?

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 CAD-CAM Abutments?

The FDA product code for Blue Sky Bio CAD-CAM Abutments 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 K201919Blue Sky Bio TAD K190491Blue Sky Bio Zygomatic Implant System K180107Blue Sky Bio Aligner

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Fonte oficial

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