FDA 510(k)

Image Fast Set, Image Regular Set

Número K: K160097 · 2016-08-05

Data da decisão2016-08-05

Código do produtoELW

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Image Fast Set, Image Regular Set is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties. It received FDA 510(k) clearance on 2016-08-05 under 510(k) number K160097. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Image Fast Set, Image Regular Set?

Image Fast Set, Image Regular Set is a medical device that received FDA 510(k) clearance on 2016-08-05. The listed applicant is Sybron Dental Specialties. The 510(k) number is K160097.

When did Image Fast Set, Image Regular Set receive FDA 510(k) clearance?

Image Fast Set, Image Regular Set received FDA 510(k) clearance on 2016-08-05, under 510(k) number K160097.

Who is the listed applicant for Image Fast Set, Image Regular Set?

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

What is the FDA product code for Image Fast Set, Image Regular Set?

The FDA product code for Image Fast Set, Image Regular Set is ELW.

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Dispositivos Relacionados (Código: ELW)

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Fonte oficial

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