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FDA 510(k)

帕克牙科尼龍MAD

K 號:K252976 · 2025-12-18

決定日期2025-12-18
產品代碼LRK
諮詢委員會DE
決定相當於

器材摘要

Park Dental Nylon MAD is the device name listed in this FDA 510(k) record. The listed applicant is Park Dental Research Corp.. It received FDA 510(k) clearance on 2025-12-18 under 510(k) number K252976. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Park Dental Nylon MAD?

Park Dental Nylon MAD is a medical device that received FDA 510(k) clearance on 2025-12-18. The listed applicant is Park Dental Research Corp.. The 510(k) number is K252976.

When did Park Dental Nylon MAD receive FDA 510(k) clearance?

Park Dental Nylon MAD received FDA 510(k) clearance on 2025-12-18, under 510(k) number K252976.

Who is the listed applicant for Park Dental Nylon MAD?

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

What is the FDA product code for Park Dental Nylon MAD?

The FDA product code for Park Dental Nylon MAD is LRK.

相關臨床試驗

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相關器械(代碼:LRK)

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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