FDA 510(k)

JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST

Número K: K250969 · 2025-06-27

Data da decisão2025-06-27

Código do produtoELW

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST is the device name listed in this FDA 510(k) record. The listed applicant is Dent4you AG. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K250969. 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 JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST?

JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Dent4you AG. The 510(k) number is K250969.

When did JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST receive FDA 510(k) clearance?

JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST received FDA 510(k) clearance on 2025-06-27, under 510(k) number K250969.

Who is the listed applicant for JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST?

The FDA 510(k) record lists Dent4you AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST?

The FDA product code for JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST is ELW.

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Dispositivos Relacionados (Código: ELW)

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