FDA 510(k)

3M™ VitCal Liner/Base

K 號：K230270 · 2023-02-06

決定日期2023-02-06

產品代碼EJK

諮詢委員會DE

決定相當於

器材摘要

3M™ VitCal Liner/Base is the device name listed in this FDA 510(k) record. The listed applicant is 3M Espe Dental Products. It received FDA 510(k) clearance on 2023-02-06 under 510(k) number K230270. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 3M™ VitCal Liner/Base?

3M™ VitCal Liner/Base is a medical device that received FDA 510(k) clearance on 2023-02-06. The listed applicant is 3M Espe Dental Products. The 510(k) number is K230270.

When did 3M™ VitCal Liner/Base receive FDA 510(k) clearance?

3M™ VitCal Liner/Base received FDA 510(k) clearance on 2023-02-06, under 510(k) number K230270.

Who is the listed applicant for 3M™ VitCal Liner/Base?

The FDA 510(k) record lists 3M Espe Dental Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M™ VitCal Liner/Base?

The FDA product code for 3M™ VitCal Liner/Base is EJK.

其他以 3M Espe Dental Products 為申請人之記錄

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相關器械（代碼：EJK）

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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