FDA 510(k)

EVOLUX CAD/CAM PMMA BLOCKS

Número K: K182065 · 2018-12-13

Data da decisão2018-12-13

Código do produtoEBG

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

EVOLUX CAD/CAM PMMA BLOCKS is the device name listed in this FDA 510(k) record. The listed applicant is Blue Dent Dental. It received FDA 510(k) clearance on 2018-12-13 under 510(k) number K182065. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EVOLUX CAD/CAM PMMA BLOCKS?

EVOLUX CAD/CAM PMMA BLOCKS is a medical device that received FDA 510(k) clearance on 2018-12-13. The listed applicant is Blue Dent Dental. The 510(k) number is K182065.

When did EVOLUX CAD/CAM PMMA BLOCKS receive FDA 510(k) clearance?

EVOLUX CAD/CAM PMMA BLOCKS received FDA 510(k) clearance on 2018-12-13, under 510(k) number K182065.

Who is the listed applicant for EVOLUX CAD/CAM PMMA BLOCKS?

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

What is the FDA product code for EVOLUX CAD/CAM PMMA BLOCKS?

The FDA product code for EVOLUX CAD/CAM PMMA BLOCKS is EBG.

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