FDA 510(k)

Emerald Herbst

Número K: K223624 · 2023-05-10

RequerenteIsland Dental Lab, Inc Dba Emerald Dental

Data da decisão2023-05-10

Código do produtoLRK

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Emerald Herbst is the device name listed in this FDA 510(k) record. The listed applicant is Island Dental Lab, Inc Dba Emerald Dental. It received FDA 510(k) clearance on 2023-05-10 under 510(k) number K223624. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Emerald Herbst?

Emerald Herbst is a medical device that received FDA 510(k) clearance on 2023-05-10. The listed applicant is Island Dental Lab, Inc Dba Emerald Dental. The 510(k) number is K223624.

When did Emerald Herbst receive FDA 510(k) clearance?

Emerald Herbst received FDA 510(k) clearance on 2023-05-10, under 510(k) number K223624.

Who is the listed applicant for Emerald Herbst?

The FDA 510(k) record lists Island Dental Lab, Inc Dba Emerald Dental as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Emerald Herbst?

The FDA product code for Emerald Herbst is LRK.

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Fonte oficial

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