FDA 510(k)

Burn-out Cylinder and Angled Screw Abutments

Número K: K160483 · 2016-08-05

Data da decisão2016-08-05

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Burn-out Cylinder and Angled Screw Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Dentium Co., Ltd.. It received FDA 510(k) clearance on 2016-08-05 under 510(k) number K160483. 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 Burn-out Cylinder and Angled Screw Abutments?

Burn-out Cylinder and Angled Screw Abutments is a medical device that received FDA 510(k) clearance on 2016-08-05. The listed applicant is Dentium Co., Ltd.. The 510(k) number is K160483.

When did Burn-out Cylinder and Angled Screw Abutments receive FDA 510(k) clearance?

Burn-out Cylinder and Angled Screw Abutments received FDA 510(k) clearance on 2016-08-05, under 510(k) number K160483.

Who is the listed applicant for Burn-out Cylinder and Angled Screw Abutments?

The FDA 510(k) record lists Dentium Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Burn-out Cylinder and Angled Screw Abutments?

The FDA product code for Burn-out Cylinder and Angled Screw Abutments is NHA.

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Fonte oficial

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