FDA 510(k)

BTI Dental Implant System UnicCa® – Aesthetic Post Abutments

Número K: K231827 · 2023-09-15

RequerenteB.T.I. Biotechnology Institute, Sl.

Data da decisão2023-09-15

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

BTI Dental Implant System UnicCa® – Aesthetic Post Abutments is the device name listed in this FDA 510(k) record. The listed applicant is B.T.I. Biotechnology Institute, Sl.. It received FDA 510(k) clearance on 2023-09-15 under 510(k) number K231827. 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 BTI Dental Implant System UnicCa® – Aesthetic Post Abutments?

BTI Dental Implant System UnicCa® – Aesthetic Post Abutments is a medical device that received FDA 510(k) clearance on 2023-09-15. The listed applicant is B.T.I. Biotechnology Institute, Sl.. The 510(k) number is K231827.

When did BTI Dental Implant System UnicCa® – Aesthetic Post Abutments receive FDA 510(k) clearance?

BTI Dental Implant System UnicCa® – Aesthetic Post Abutments received FDA 510(k) clearance on 2023-09-15, under 510(k) number K231827.

Who is the listed applicant for BTI Dental Implant System UnicCa® – Aesthetic Post Abutments?

The FDA 510(k) record lists B.T.I. Biotechnology Institute, Sl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BTI Dental Implant System UnicCa® – Aesthetic Post Abutments?

The FDA product code for BTI Dental Implant System UnicCa® – Aesthetic Post Abutments is NHA.

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Fonte oficial

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