FDA 510(k)

Denture Base

N.º K: K243103 · 2024-12-23

SolicitanteRiton 3D Technology Co., Ltd.

Fecha de decisión2024-12-23

Código de productoEBI

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Denture Base is the device name listed in this FDA 510(k) record. The listed applicant is Riton 3D Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-12-23 under 510(k) number K243103. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Denture Base?

Denture Base is a medical device that received FDA 510(k) clearance on 2024-12-23. The listed applicant is Riton 3D Technology Co., Ltd.. The 510(k) number is K243103.

When did Denture Base receive FDA 510(k) clearance?

Denture Base received FDA 510(k) clearance on 2024-12-23, under 510(k) number K243103.

Who is the listed applicant for Denture Base?

The FDA 510(k) record lists Riton 3D Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Denture Base?

The FDA product code for Denture Base is EBI.

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Dispositivos relacionados (Código: EBI)

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.

Fuente oficial

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