FDA 510(k)

TiGEN 牙槽，PMMA 牙槽及掃描復原牙槽

K 號：K234142 · 2024-09-18

決定日期2024-09-18

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

TiGEN Abutment, PMMA Abutment and Scan Healing 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 2024-09-18 under 510(k) number K234142. 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 TiGEN Abutment, PMMA Abutment and Scan Healing Abutment?

TiGEN Abutment, PMMA Abutment and Scan Healing Abutment is a medical device that received FDA 510(k) clearance on 2024-09-18. The listed applicant is Megagen Implant Co., Ltd.. The 510(k) number is K234142.

When did TiGEN Abutment, PMMA Abutment and Scan Healing Abutment receive FDA 510(k) clearance?

TiGEN Abutment, PMMA Abutment and Scan Healing Abutment received FDA 510(k) clearance on 2024-09-18, under 510(k) number K234142.

Who is the listed applicant for TiGEN Abutment, PMMA Abutment and Scan Healing 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 TiGEN Abutment, PMMA Abutment and Scan Healing Abutment?

The FDA product code for TiGEN Abutment, PMMA Abutment and Scan Healing 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 K242030麥格基因牙植體基座 K241972藍寶石植入體 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。

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官方來源

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