FDA 510(k)

CreoDent Solidex 訂製牙根台

K 號：K160436 · 2016-09-29

決定日期2016-09-29

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

CreoDent Solidex Custom Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Creodent Prosthetics, Ltd.. It received FDA 510(k) clearance on 2016-09-29 under 510(k) number K160436. 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 CreoDent Solidex Custom Abutment?

CreoDent Solidex Custom Abutment is a medical device that received FDA 510(k) clearance on 2016-09-29. The listed applicant is Creodent Prosthetics, Ltd.. The 510(k) number is K160436.

When did CreoDent Solidex Custom Abutment receive FDA 510(k) clearance?

CreoDent Solidex Custom Abutment received FDA 510(k) clearance on 2016-09-29, under 510(k) number K160436.

Who is the listed applicant for CreoDent Solidex Custom Abutment?

The FDA 510(k) record lists Creodent Prosthetics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CreoDent Solidex Custom Abutment?

The FDA product code for CreoDent Solidex Custom Abutment is NHA.

其他以 Creodent Prosthetics, Ltd. 為申請人之記錄

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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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