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FDA 510(k)

Inclusive Abutments

K 號：K160979 · 2016-11-04

申請人Prismatik Dentalcraft, Inc.
決定日期2016-11-04
產品代碼NHA
諮詢委員會DE
決定Substantially Equivalent

器材摘要

Inclusive Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K160979. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Inclusive Abutments?

Inclusive Abutments is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K160979.

When did Inclusive Abutments receive FDA 510(k) clearance?

Inclusive Abutments received FDA 510(k) clearance on 2016-11-04, under 510(k) number K160979.

Who is the listed applicant for Inclusive Abutments?

The FDA 510(k) record lists Prismatik Dentalcraft, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Inclusive Abutments?

The FDA product code for Inclusive Abutments is NHA.

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其他以 Prismatik Dentalcraft, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261802Glidewell™ Denture Base ResinK262239Obsidian® Press Over ZirconiaK254283BruxZir® Shaded 16 PLUSK252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant SystemsK252446BruxZir® NOWK250302Flexible Partial Resin

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相關器械（代碼：NHA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLCK253999Universal 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 ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.

官方來源

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