FDA 510(k)

DESS 牙种植体智能解决方案

K号: K253804 · 2026-04-16

决定日期2026-04-16

产品代码NHA

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决定实质等同

器械摘要

DESS Dental Smart Solutions is the device name listed in this FDA 510(k) record. The listed applicant is Terrats Medical SL. It received FDA 510(k) clearance on 2026-04-16 under 510(k) number K253804. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DESS Dental Smart Solutions?

DESS Dental Smart Solutions is a medical device that received FDA 510(k) clearance on 2026-04-16. The listed applicant is Terrats Medical SL. The 510(k) number is K253804.

When did DESS Dental Smart Solutions receive FDA 510(k) clearance?

DESS Dental Smart Solutions received FDA 510(k) clearance on 2026-04-16, under 510(k) number K253804.

Who is the listed applicant for DESS Dental Smart Solutions?

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

What is the FDA product code for DESS Dental Smart Solutions?

The FDA product code for DESS Dental Smart Solutions is NHA.

列明Terrats Medical SL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。

K260564DESS 牙种植体智能解决方案 K251547DESS 牙种植体智能解决方案 K252384DESS® 牙种植体智能解决方案 K251280DESS® 牙种植体 K250639DESS 牙种植体智能解决方案 K243212DESS 牙种植体智能解决方案

查看所有 23 个设备 →

相关器械（代码：NHA）

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。

K262207水泥固定基台Unidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLC 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Nobel Biocare AB K261147Neodent植入系统 - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061BioHorizons CEREC 兼容 Ti-BasesBioHorizons Implant Systems, Inc.

官方来源

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