FDA 510(k)

GEN5® 和 GEN5+® 3.3mmD 牙科种植体

K号: K252145 · 2025-12-23

决定日期2025-12-23

产品代码DZE

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决定实质等同

器械摘要

GEN5™ and GEN5+™ 3.3mmD Dental Implants is the device name listed in this FDA 510(k) record. The listed applicant is Paragon Implant Mfg., LLC. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K252145. 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 GEN5™ and GEN5+™ 3.3mmD Dental Implants?

GEN5™ and GEN5+™ 3.3mmD Dental Implants is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Paragon Implant Mfg., LLC. The 510(k) number is K252145.

When did GEN5™ and GEN5+™ 3.3mmD Dental Implants receive FDA 510(k) clearance?

GEN5™ and GEN5+™ 3.3mmD Dental Implants received FDA 510(k) clearance on 2025-12-23, under 510(k) number K252145.

Who is the listed applicant for GEN5™ and GEN5+™ 3.3mmD Dental Implants?

FDA 510(k)记录中列出Paragon Implant Mfg., LLC为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for GEN5™ and GEN5+™ 3.3mmD Dental Implants?

The FDA product code for GEN5™ and GEN5+™ 3.3mmD Dental Implants is DZE.

列明Paragon Implant Mfg., LLC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。

K261392TriActive 牙齿种植系统 K250476NizPlant 牙齿种植系统 K251756灭菌托盘 K251938GEN5 和 GEN5+ 牙科种植系统

官方来源

在 FDA 数据库中查看 →

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。