FDA 510(k)

AlphaDent Implants Sistemas de Implantes Dentários

Número K: K180968 · 2019-07-03

Data da decisão2019-07-03

Código do produtoDZE

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

AlphaDent Implants Dental Implants System is the device name listed in this FDA 510(k) record. The listed applicant is Alphadent Implants, Ltd.. It received FDA 510(k) clearance on 2019-07-03 under 510(k) number K180968. 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 AlphaDent Implants Dental Implants System?

AlphaDent Implants Dental Implants System is a medical device that received FDA 510(k) clearance on 2019-07-03. The listed applicant is Alphadent Implants, Ltd.. The 510(k) number is K180968.

When did AlphaDent Implants Dental Implants System receive FDA 510(k) clearance?

AlphaDent Implants Dental Implants System received FDA 510(k) clearance on 2019-07-03, under 510(k) number K180968.

Who is the listed applicant for AlphaDent Implants Dental Implants System?

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

What is the FDA product code for AlphaDent Implants Dental Implants System?

The FDA product code for AlphaDent Implants Dental Implants System is DZE.

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