FDA 510(k)

Dia-X Sil Light Body

N.º K: K254152 · 2026-09-16

Fecha de decisión2026-09-16

Código de productoELW

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Dia-X Sil Light Body is the device name listed in this FDA 510(k) record. The listed applicant is DiaDent Group International. It received FDA 510(k) clearance on 2026-09-16 under 510(k) number K254152. 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 Dia-X Sil Light Body?

Dia-X Sil Light Body is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is DiaDent Group International. The 510(k) number is K254152.

When did Dia-X Sil Light Body receive FDA 510(k) clearance?

Dia-X Sil Light Body received FDA 510(k) clearance on 2026-09-16, under 510(k) number K254152.

Who is the listed applicant for Dia-X Sil Light Body?

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

What is the FDA product code for Dia-X Sil Light Body?

El código de producto de la FDA para el cuerpo ligero Dia-X Sil es ELW.

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Otros registros que enlistan a DiaDent Group International como solicitante

K254142Dia-X Sil Heavy Body K261166DIA-CEM K261093DIAFIL K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)K254112Dia-X Sil Bite K231552Dia-Cem

Ver todos los 23 dispositivos →

Dispositivos relacionados (Código: ELW)

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.K242360Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal ActivatorDent4you AG

Fuente oficial

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