FDA 510(k)

Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)

Номер K: K260152 · 2026-04-23

ЗаявительMmtech Projetos Tecnologicos Importacao E Exportacao Ltda.

Дата решения2026-04-23

Код продуктаEBF

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) is the device name listed in this FDA 510(k) record. The listed applicant is Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.. It received FDA 510(k) clearance on 2026-04-23 under 510(k) number K260152. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)?

Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) is a medical device that received FDA 510(k) clearance on 2026-04-23. The listed applicant is Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.. The 510(k) number is K260152.

When did Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) receive FDA 510(k) clearance?

Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) received FDA 510(k) clearance on 2026-04-23, under 510(k) number K260152.

Who is the listed applicant for Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)?

The FDA 510(k) record lists Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)?

The FDA product code for Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) is EBF.

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: EBF)

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

Официальный источник

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