FDA 510(k)

s-Clean 扫描修復基座

K 號：K241063 · 2024-07-25

決定日期2024-07-25

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

s-Clean ScanHealing Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Dentis Co., Ltd.. It received FDA 510(k) clearance on 2024-07-25 under 510(k) number K241063. 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 s-Clean ScanHealing Abutment?

s-Clean ScanHealing Abutment is a medical device that received FDA 510(k) clearance on 2024-07-25. The listed applicant is Dentis Co., Ltd.. The 510(k) number is K241063.

When did s-Clean ScanHealing Abutment receive FDA 510(k) clearance?

s-Clean ScanHealing Abutment received FDA 510(k) clearance on 2024-07-25, under 510(k) number K241063.

Who is the listed applicant for s-Clean ScanHealing Abutment?

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

What is the FDA product code for s-Clean ScanHealing Abutment?

The FDA product code for s-Clean ScanHealing Abutment is NHA.

其他以 Dentis 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。

K253493牙醫SQ-SL AXEL固定器 K241065ChecQ (AC100)K233921Luvis 椅子 (LC700C)K240511牙醫s-Clean SQ-SL 裝置 K233544MESHEET 注意：此文本中未提供具体的医疗设备名称或相关监管文本，因此无法进行翻译。请提供具体的文本内容以便进行翻译。K230126牙醫s-Clean標準牙根擴張體

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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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