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FDA 510(k)

Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant

K号: K252731 · 2026-05-12

申请人Promimic AB
决定日期2026-05-12
产品代码DZE
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决定实质等同

器械摘要

Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant is the device name listed in this FDA 510(k) record. The listed applicant is Promimic AB. It received FDA 510(k) clearance on 2026-05-12 under 510(k) number K252731. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant?

Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant is a medical device that received FDA 510(k) clearance on 2026-05-12. The listed applicant is Promimic AB. The 510(k) number is K252731.

When did Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant receive FDA 510(k) clearance?

Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant received FDA 510(k) clearance on 2026-05-12, under 510(k) number K252731.

Who is the listed applicant for Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant?

The FDA 510(k) record lists Promimic AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant?

The FDA product code for Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant is DZE.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：DZE）

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。

K261392TriActive 牙齿种植系统Paragon Implant Mfg., LLCK260463ZEROS 牙齿种植系统Zeros Co., Ltd.K251188UNIQA® 牙齿种植系统Uniqa Dental, Ltd.K251232MegaGen颧骨牙科植入系统Megagen Implant Co., Ltd.K250806牙科植入系统A.B. Dental Devices , Ltd.K260006INOSS 系统Inosys, Inc.

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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