FDA 510(k)

DTX Studio 诊所（4.0）

K号: K231898 · 2023-12-08

决定日期2023-12-08

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

DTX Studio Clinic (4.0) 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 2023-12-08 under 510(k) number K231898. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DTX Studio Clinic (4.0)?

DTX Studio Clinic (4.0) is a medical device that received FDA 510(k) clearance on 2023-12-08. The listed applicant is Nobel Biocare AB. The 510(k) number is K231898.

When did DTX Studio Clinic (4.0) receive FDA 510(k) clearance?

DTX Studio Clinic (4.0) received FDA 510(k) clearance on 2023-12-08, under 510(k) number K231898.

Who is the listed applicant for DTX Studio Clinic (4.0)?

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 DTX Studio Clinic (4.0)?

The FDA product code for DTX Studio Clinic (4.0) is LLZ.

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 K252197Nobel Biocare S 系列种植体 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

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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。