FDA 510(k)

Pac-Dent 鈷酸鹽纳米雙組合树脂

K 號：K210412 · 2021-07-26

決定日期2021-07-26

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Pac-Dent Ceramic Nanohybrid 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 2021-07-26 under 510(k) number K210412. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pac-Dent Ceramic Nanohybrid Resin?

Pac-Dent Ceramic Nanohybrid Resin is a medical device that received FDA 510(k) clearance on 2021-07-26. The listed applicant is Pac-Dent, Inc.. The 510(k) number is K210412.

When did Pac-Dent Ceramic Nanohybrid Resin receive FDA 510(k) clearance?

Pac-Dent Ceramic Nanohybrid Resin received FDA 510(k) clearance on 2021-07-26, under 510(k) number K210412.

Who is the listed applicant for Pac-Dent Ceramic Nanohybrid 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 Ceramic Nanohybrid Resin?

The FDA product code for Pac-Dent Ceramic Nanohybrid Resin is EBF.

其他以 Pac-Dent, Inc. 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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