FDA 510(k)

Nobel Biocare S 系列种植体

K号: K252197 · 2026-02-18

决定日期2026-02-18

产品代码DZE

咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。

决定实质等同

器械摘要

Nobel Biocare S Series Implants is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare AB. It received FDA 510(k) clearance on 2026-02-18 under 510(k) number K252197. 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 Nobel Biocare S Series Implants?

Nobel Biocare S Series Implants is a medical device that received FDA 510(k) clearance on 2026-02-18. The listed applicant is Nobel Biocare AB. The 510(k) number is K252197.

When did Nobel Biocare S Series Implants receive FDA 510(k) clearance?

Nobel Biocare S Series Implants received FDA 510(k) clearance on 2026-02-18, under 510(k) number K252197.

Who is the listed applicant for Nobel Biocare S Series Implants?

FDA 510(k)记录显示诺贝尔生物护理AB为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Nobel Biocare S Series Implants?

The FDA product code for Nobel Biocare S Series Implants is DZE.

列明Nobel Biocare AB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。

K253988LiteSet托盘 K253999通用底座 ASC 启动；通用底座 ASC 非启动；通用底座 MUA ASC；临时基台启动和非启动；愈合基台锥形连接；Omnigrip 临床螺丝钛；Omnigrip 假体螺丝 K243834NobelZygoma TiUltra 植入系统 K240346NobelProcera 氧化锆植入体桥 K233208NobelProcera 钛合金 ASC 套管，Omnigrip 临床螺丝钛合金 K231898DTX Studio 诊所（4.0）

查看所有 41 个设备 →

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。