FDA 510(k)

CEREC 識別器基座系統

K 號：K252248 · 2025-11-26

決定日期2025-11-26

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

CEREC Tessera Abutment System is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2025-11-26 under 510(k) number K252248. 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 CEREC Tessera Abutment System?

CEREC Tessera Abutment System is a medical device that received FDA 510(k) clearance on 2025-11-26. The listed applicant is Dentsply Sirona. The 510(k) number is K252248.

When did CEREC Tessera Abutment System receive FDA 510(k) clearance?

CEREC Tessera Abutment System received FDA 510(k) clearance on 2025-11-26, under 510(k) number K252248.

Who is the listed applicant for CEREC Tessera Abutment System?

FDA 510(k) 記錄將 Dentsply Sirona 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for CEREC Tessera Abutment System?

The FDA product code for CEREC Tessera Abutment System is NHA.

其他以 Dentsply Sirona 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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