FDA 510(k)

多匹配流蜥蜴抗菌複合材

K 號：K253513 · 2025-11-07

決定日期2025-11-07

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

MultiMatch Flow Chameleon AntiMicrobial 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 2025-11-07 under 510(k) number K253513. 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 MultiMatch Flow Chameleon AntiMicrobial Composite?

MultiMatch Flow Chameleon AntiMicrobial Composite is a medical device that received FDA 510(k) clearance on 2025-11-07. The listed applicant is Premier Dental Products Company. The 510(k) number is K253513.

When did MultiMatch Flow Chameleon AntiMicrobial Composite receive FDA 510(k) clearance?

MultiMatch Flow Chameleon AntiMicrobial Composite received FDA 510(k) clearance on 2025-11-07, under 510(k) number K253513.

Who is the listed applicant for MultiMatch Flow Chameleon AntiMicrobial 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 MultiMatch Flow Chameleon AntiMicrobial Composite?

The FDA product code for MultiMatch Flow Chameleon AntiMicrobial Composite is EBF.

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

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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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