FDA 510(k)

Spiral Shape Dental Implant System

Número K: K162299 · 2017-06-22

Data da decisão2017-06-22

Código do produtoDZE

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Spiral Shape Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Gp Implants. It received FDA 510(k) clearance on 2017-06-22 under 510(k) number K162299. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Spiral Shape Dental Implant System?

Spiral Shape Dental Implant System is a medical device that received FDA 510(k) clearance on 2017-06-22. The listed applicant is Gp Implants. The 510(k) number is K162299.

When did Spiral Shape Dental Implant System receive FDA 510(k) clearance?

Spiral Shape Dental Implant System received FDA 510(k) clearance on 2017-06-22, under 510(k) number K162299.

Who is the listed applicant for Spiral Shape Dental Implant System?

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

What is the FDA product code for Spiral Shape Dental Implant System?

The FDA product code for Spiral Shape Dental Implant System is DZE.

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