FDA 510(k)

麥格基因牙植體基座

K 號：K242030 · 2025-01-13

決定日期2025-01-13

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

MegaGen Dental Implant Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2025-01-13 under 510(k) number K242030. 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 MegaGen Dental Implant Abutment?

MegaGen Dental Implant Abutment is a medical device that received FDA 510(k) clearance on 2025-01-13. The listed applicant is Megagen Implant Co., Ltd.. The 510(k) number is K242030.

When did MegaGen Dental Implant Abutment receive FDA 510(k) clearance?

MegaGen Dental Implant Abutment received FDA 510(k) clearance on 2025-01-13, under 510(k) number K242030.

Who is the listed applicant for MegaGen Dental Implant Abutment?

The FDA 510(k) record lists Megagen Implant Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MegaGen Dental Implant Abutment?

The FDA product code for MegaGen Dental Implant Abutment is NHA.

其他以 Megagen Implant Co., Ltd. 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。

K251232MegaGen 遺傳子顎骨牙植體系統 K241972藍寶石植入體 K234142TiGEN 牙槽，PMMA 牙槽及掃描復原牙槽 K240754N2：N2 (注意：原文中未提供具体的医疗设备名称或相关文本，因此翻译为“N2”以保持原文样貌。)K233450MegaGen 齒科植體基座 - 扫描愈合基座；臨時基座；臨時柱；舒適帽；愈合帽；愈合帽螺釘；磨削基座；EZ Post 基座；超EZ Post 基座；EZ Post 柱；ZrGEN 基座；多單位基座；多單位斜角基座；AXA 基座（直角）；AXA 基座（斜角）；基座螺釘；柱螺釘；牙冠螺釘 K231967ARi ExCon植入系統

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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。