FDA 510(k)

NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium

Número K: K233208 · 2024-01-24

Data da decisão2024-01-24

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare AB. It received FDA 510(k) clearance on 2024-01-24 under 510(k) number K233208. 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 NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium?

NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium is a medical device that received FDA 510(k) clearance on 2024-01-24. The listed applicant is Nobel Biocare AB. The 510(k) number is K233208.

When did NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium receive FDA 510(k) clearance?

NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium received FDA 510(k) clearance on 2024-01-24, under 510(k) number K233208.

Who is the listed applicant for NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium?

The FDA 510(k) record lists Nobel Biocare AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium?

The FDA product code for NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium is NHA.

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Fonte oficial

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