FDA 510(k)

領先者多合一口罩變色修復複合材料

K 號：K223632 · 2022-12-06

決定日期2022-12-06

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Premier's MultiMatch Universal Chameleon Restorative Composite is the device name listed in this FDA 510(k) record. The listed applicant is Premier Dental Products Company. It received FDA 510(k) clearance on 2022-12-06 under 510(k) number K223632. 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 Premier's MultiMatch Universal Chameleon Restorative Composite?

Premier's MultiMatch Universal Chameleon Restorative Composite is a medical device that received FDA 510(k) clearance on 2022-12-06. The listed applicant is Premier Dental Products Company. The 510(k) number is K223632.

When did Premier's MultiMatch Universal Chameleon Restorative Composite receive FDA 510(k) clearance?

Premier's MultiMatch Universal Chameleon Restorative Composite received FDA 510(k) clearance on 2022-12-06, under 510(k) number K223632.

Who is the listed applicant for Premier's MultiMatch Universal Chameleon Restorative Composite?

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

What is the FDA product code for Premier's MultiMatch Universal Chameleon Restorative Composite?

The FDA product code for Premier's MultiMatch Universal Chameleon Restorative Composite is EBF.

其他以 Premier Dental Products Company 為申請人之記錄

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。

K260682Bond-PR™ 過敏性膠粘劑 K253513多匹配流蜥蜴抗菌複合材

相關器械（代碼：EBF）

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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