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FDA 510(k)

全方位多單元牙槽體系統（商標名稱：Omnibut™）

K 號：K242064 · 2025-01-17

申請人Smart Denture Conversions, LLC
決定日期2025-01-17
產品代碼NHA
諮詢委員會DE
決定相當於

器材摘要

Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) is the device name listed in this FDA 510(k) record. The listed applicant is Smart Denture Conversions, LLC. It received FDA 510(k) clearance on 2025-01-17 under 510(k) number K242064. 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 Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)?

Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) is a medical device that received FDA 510(k) clearance on 2025-01-17. The listed applicant is Smart Denture Conversions, LLC. The 510(k) number is K242064.

When did Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) receive FDA 510(k) clearance?

Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) received FDA 510(k) clearance on 2025-01-17, under 510(k) number K242064.

Who is the listed applicant for Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)?

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

What is the FDA product code for Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)?

The FDA product code for Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) is NHA.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Smart Denture Conversions, LLC 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。

K254145全方位多單元牙槽體系統（商標名稱：Omnibut™）

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, LLCK253999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 ABK261147Neodent植牙系統 - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061生物地平線 CEREC 兼容 Ti-BasesBioHorizons Implant Systems, Inc.

官方來源

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