FDA 510(k)

Inclusive® 钛金牙根座，相容於：Camlog® CONELOG® 植牙系統，Dentium® NR Line 植牙系統

K 號：K252582 · 2025-11-18

決定日期2025-11-18

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems 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 2025-11-18 under 510(k) number K252582. 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® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems?

Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems is a medical device that received FDA 510(k) clearance on 2025-11-18. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K252582.

When did Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems receive FDA 510(k) clearance?

Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems received FDA 510(k) clearance on 2025-11-18, under 510(k) number K252582.

Who is the listed applicant for Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems?

FDA 510(k) 記錄將 Prismatik Dentalcraft, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems?

The FDA product code for Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems is NHA.

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。

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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。

K262207固定式加長基座Unidental Co., Ltd.K260940貝拉特克條ZimVie US Corp, LLC K253999通用基座 ASC 接合；通用基座 ASC 非接合；通用基座 MUA ASC；臨時基座接合和非接合；恢復基座極锥連接；Omnigrip臨床螺釘鈦金；Omnigrip假牙螺釘Nobel Biocare AB K261147Neodent植牙系統 - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061生物地平線 CEREC 兼容 Ti-BasesBioHorizons Implant Systems, Inc.

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。