FDA 510(k)

BioClean Implant Restorative System

Номер K: K222984 · 2022-12-29

Дата решения2022-12-29

Код продуктаNHA

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

BioClean Implant Restorative System is the device name listed in this FDA 510(k) record. The listed applicant is Bioclean Dental, LLC. It received FDA 510(k) clearance on 2022-12-29 under 510(k) number K222984. 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 BioClean Implant Restorative System?

BioClean Implant Restorative System is a medical device that received FDA 510(k) clearance on 2022-12-29. The listed applicant is Bioclean Dental, LLC. The 510(k) number is K222984.

When did BioClean Implant Restorative System receive FDA 510(k) clearance?

BioClean Implant Restorative System received FDA 510(k) clearance on 2022-12-29, under 510(k) number K222984.

Who is the listed applicant for BioClean Implant Restorative System?

The FDA 510(k) record lists Bioclean Dental, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioClean Implant Restorative System?

The FDA product code for BioClean Implant Restorative System 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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