FDA 510(k)

Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator

N.º K: K242360 · 2024-11-15

Fecha de decisión2024-11-15

Código de productoELW

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator is the device name listed in this FDA 510(k) record. The listed applicant is Dent4you AG. It received FDA 510(k) clearance on 2024-11-15 under 510(k) number K242360. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator?

Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator is a medical device that received FDA 510(k) clearance on 2024-11-15. The listed applicant is Dent4you AG. The 510(k) number is K242360.

When did Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator receive FDA 510(k) clearance?

Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator received FDA 510(k) clearance on 2024-11-15, under 510(k) number K242360.

Who is the listed applicant for Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator?

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 Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator?

The FDA product code for Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator is ELW.

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Otros registros que enlistan a Dent4you AG como solicitante

K250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST K240801BioSonic US200 Ultrasonic Scaler (60034537)K223142Coltolux Comfort LED Curing Light

Dispositivos relacionados (Código: ELW)

K254152Dia-X Sil Light BodyDiaDent Group International K254142Dia-X Sil Heavy BodyDiaDent Group International K254112Dia-X Sil BiteDiaDent Group International K253501Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);Vigodent Indústria E Comercio Ltda K250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFASTDent4you AG K241924Elastic Impression MaterialBeijing Okvd Biological Technology , Ltd.

Fuente oficial

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