FDA 510(k)

PRE-MILLED Abutment

Номер K: K202269 · 2020-11-25

Дата решения2020-11-25

Код продуктаNHA

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

PRE-MILLED Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Mit Global Co., Ltd.. It received FDA 510(k) clearance on 2020-11-25 under 510(k) number K202269. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the PRE-MILLED Abutment?

PRE-MILLED Abutment is a medical device that received FDA 510(k) clearance on 2020-11-25. The listed applicant is Mit Global Co., Ltd.. The 510(k) number is K202269.

When did PRE-MILLED Abutment receive FDA 510(k) clearance?

PRE-MILLED Abutment received FDA 510(k) clearance on 2020-11-25, under 510(k) number K202269.

Who is the listed applicant for PRE-MILLED Abutment?

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

What is the FDA product code for PRE-MILLED Abutment?

The FDA product code for PRE-MILLED Abutment is NHA.

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: NHA)

K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLC K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare AB K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.

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