FDA 510(k)

Pac-Dent 義齒基底樹脂

K 號：K210189 · 2021-07-28

決定日期2021-07-28

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

Pac-Dent Denture Base Resin is the device name listed in this FDA 510(k) record. The listed applicant is Pac-Dent, Inc.. It received FDA 510(k) clearance on 2021-07-28 under 510(k) number K210189. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pac-Dent Denture Base Resin?

Pac-Dent Denture Base Resin is a medical device that received FDA 510(k) clearance on 2021-07-28. The listed applicant is Pac-Dent, Inc.. The 510(k) number is K210189.

When did Pac-Dent Denture Base Resin receive FDA 510(k) clearance?

Pac-Dent Denture Base Resin received FDA 510(k) clearance on 2021-07-28, under 510(k) number K210189.

Who is the listed applicant for Pac-Dent Denture Base Resin?

The FDA 510(k) record lists Pac-Dent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pac-Dent Denture Base Resin?

The FDA product code for Pac-Dent Denture Base Resin is EBI.

其他以 Pac-Dent, Inc. 為申請人之記錄

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相關器械（代碼：EBI）

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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