FDA 510(k)

PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement

Número K: K152652 · 2016-04-05

Data da decisão2016-04-05

Código do produtoEMA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement is the device name listed in this FDA 510(k) record. The listed applicant is Gaia Dental Products, Inc.. It received FDA 510(k) clearance on 2016-04-05 under 510(k) number K152652. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement?

PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement is a medical device that received FDA 510(k) clearance on 2016-04-05. The listed applicant is Gaia Dental Products, Inc.. The 510(k) number is K152652.

When did PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement receive FDA 510(k) clearance?

PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement received FDA 510(k) clearance on 2016-04-05, under 510(k) number K152652.

Who is the listed applicant for PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement?

The FDA 510(k) record lists Gaia Dental Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement?

The FDA product code for PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement is EMA.

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