FDA 510(k)

zirkon; structure; LFU shades, stains and glazes

Номер K: K251084 · 2025-06-05

Дата решения2025-06-05

Код продуктаEIH

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

zirkon; structure; LFU shades, stains and glazes is the device name listed in this FDA 510(k) record. The listed applicant is Estetic Ceram AG. It received FDA 510(k) clearance on 2025-06-05 under 510(k) number K251084. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the zirkon; structure; LFU shades, stains and glazes?

zirkon; structure; LFU shades, stains and glazes is a medical device that received FDA 510(k) clearance on 2025-06-05. The listed applicant is Estetic Ceram AG. The 510(k) number is K251084.

When did zirkon; structure; LFU shades, stains and glazes receive FDA 510(k) clearance?

zirkon; structure; LFU shades, stains and glazes received FDA 510(k) clearance on 2025-06-05, under 510(k) number K251084.

Who is the listed applicant for zirkon; structure; LFU shades, stains and glazes?

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

What is the FDA product code for zirkon; structure; LFU shades, stains and glazes?

The FDA product code for zirkon; structure; LFU shades, stains and glazes is EIH.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: 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.

Официальный источник

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