FDA 510(k)

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K 號：K233935 · 2024-04-05

決定日期2024-04-05

產品代碼NXC

諮詢委員會DE

決定相當於

器材摘要

DigiLine Direct Print Aligner System is the device name listed in this FDA 510(k) record. The listed applicant is Park Dental Research Corporation. It received FDA 510(k) clearance on 2024-04-05 under 510(k) number K233935. 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 DigiLine Direct Print Aligner System?

DigiLine Direct Print Aligner System is a medical device that received FDA 510(k) clearance on 2024-04-05. The listed applicant is Park Dental Research Corporation. The 510(k) number is K233935.

When did DigiLine Direct Print Aligner System receive FDA 510(k) clearance?

DigiLine Direct Print Aligner System received FDA 510(k) clearance on 2024-04-05, under 510(k) number K233935.

Who is the listed applicant for DigiLine Direct Print Aligner System?

The FDA 510(k) record lists Park Dental Research Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DigiLine Direct Print Aligner System?

The FDA product code for DigiLine Direct Print Aligner System is NXC.

其他以 Park Dental Research Corporation 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。

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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。

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官方來源

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