FDA 510(k)

MultiMatch Flow Chameleon抗菌复合材料

K号: K253513 · 2025-11-07

决定日期2025-11-07

产品代码EBF

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决定实质等同

器械摘要

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.

常见问题

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.

列明Premier Dental Products Company为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260682Bond-PR® 通用粘合剂 K223632Premier 的 MultiMatch 通用变色龙修复复合体

官方来源

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