克麗絲潔對齊器
K 號：K182388 · 2019-12-19
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器材摘要
Krystal Klear Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Shatkin F.I.R.S.T., LLC. It received FDA 510(k) clearance on 2019-12-19 under 510(k) number K182388. 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 Krystal Klear Aligners?
Krystal Klear Aligners is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is Shatkin F.I.R.S.T., LLC. The 510(k) number is K182388.
When did Krystal Klear Aligners receive FDA 510(k) clearance?
Krystal Klear Aligners received FDA 510(k) clearance on 2019-12-19, under 510(k) number K182388.
Who is the listed applicant for Krystal Klear Aligners?
The FDA 510(k) record lists Shatkin F.I.R.S.T., LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Krystal Klear Aligners?
The FDA product code for Krystal Klear Aligners is NXC.
相關臨床試驗
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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
在 FDA 資料庫中查看 →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。
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