FDA 510(k)

牙醫s-Clean標準牙根擴張體

K 號：K230126 · 2023-08-04

決定日期2023-08-04

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Dentis s-Clean Regular 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 2023-08-04 under 510(k) number K230126. 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 Dentis s-Clean Regular Abutment?

Dentis s-Clean Regular Abutment is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Dentis Co., Ltd.. The 510(k) number is K230126.

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

Dentis s-Clean Regular Abutment received FDA 510(k) clearance on 2023-08-04, under 510(k) number K230126.

Who is the listed applicant for Dentis s-Clean Regular 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 Dentis s-Clean Regular Abutment?

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

其他以 Dentis Co., Ltd. 為申請人之記錄

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K253493牙醫SQ-SL AXEL固定器 K241065ChecQ (AC100)K233921Luvis 椅子 (LC700C)K241063s-Clean 扫描修復基座 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。

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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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