FDA 510(k)

Dental Glass Ceramics Blocks (HT, LT, MT)

Número K: K242407 · 2024-11-13

RequerenteHunan Vsmile Biotechnology Co., Ltd.

Data da decisão2024-11-13

Código do produtoEIH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dental Glass Ceramics Blocks (HT, LT, MT) is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Vsmile Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-11-13 under 510(k) number K242407. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Dental Glass Ceramics Blocks (HT, LT, MT)?

Dental Glass Ceramics Blocks (HT, LT, MT) is a medical device that received FDA 510(k) clearance on 2024-11-13. The listed applicant is Hunan Vsmile Biotechnology Co., Ltd.. The 510(k) number is K242407.

When did Dental Glass Ceramics Blocks (HT, LT, MT) receive FDA 510(k) clearance?

Dental Glass Ceramics Blocks (HT, LT, MT) received FDA 510(k) clearance on 2024-11-13, under 510(k) number K242407.

Who is the listed applicant for Dental Glass Ceramics Blocks (HT, LT, MT)?

The FDA 510(k) record lists Hunan Vsmile Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Glass Ceramics Blocks (HT, LT, MT)?

The FDA product code for Dental Glass Ceramics Blocks (HT, LT, MT) is EIH.

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Outros registros que listam Hunan Vsmile Biotechnology Co., Ltd. como candidato(a)

K221242Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Dispositivos Relacionados (Código: EIH)

K262074Any-ZircosMediclus Co., Ltd.K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba Dandy K260918Zolid LunarisAmann Girrbach AG K260859Rosetta SM, Rosetta SPHass Corp.

Fonte oficial

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