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FDA 510(k)

牙科正畸器

K 號:K222918 · 2022-11-25

決定日期2022-11-25
產品代碼NXC
諮詢委員會DE
決定相當於

器材摘要

DentCare Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Dentcare Dental Lab Pvt , Ltd.. It received FDA 510(k) clearance on 2022-11-25 under 510(k) number K222918. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DentCare Aligners?

DentCare Aligners is a medical device that received FDA 510(k) clearance on 2022-11-25. The listed applicant is Dentcare Dental Lab Pvt , Ltd.. The 510(k) number is K222918.

When did DentCare Aligners receive FDA 510(k) clearance?

DentCare Aligners received FDA 510(k) clearance on 2022-11-25, under 510(k) number K222918.

Who is the listed applicant for DentCare Aligners?

The FDA 510(k) record lists Dentcare Dental Lab Pvt , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DentCare Aligners?

The FDA product code for DentCare Aligners is NXC.

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相關器械(代碼:NXC)

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。

官方來源

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