OsteoSync™ Ti 牙齿网状材料
K号: K202918 · 2021-07-14
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决定日期2021-07-14
产品代码JEY
咨询委员会DE
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决定实质等同
器械摘要
OsteoSync™ Ti Dental Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Sites Medical, LLC. It received FDA 510(k) clearance on 2021-07-14 under 510(k) number K202918. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OsteoSync™ Ti Dental Mesh?
OsteoSync™ Ti Dental Mesh is a medical device that received FDA 510(k) clearance on 2021-07-14. The listed applicant is Sites Medical, LLC. The 510(k) number is K202918.
When did OsteoSync™ Ti Dental Mesh receive FDA 510(k) clearance?
OsteoSync™ Ti Dental Mesh received FDA 510(k) clearance on 2021-07-14, under 510(k) number K202918.
Who is the listed applicant for OsteoSync™ Ti Dental Mesh?
The FDA 510(k) record lists Sites Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OsteoSync™ Ti Dental Mesh?
The FDA product code for OsteoSync™ Ti Dental Mesh is JEY.
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。
相关器械（代码：JEY）
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。
K260137KLS Martin IPS 口腔-Max 种植体 - MR 条件性；个体化患者解决方案 - Ti (IPS-Ti)；个体化患者解决方案 - PEEK (IPS-PEEK)；KLS Martin 个体化患者解决方案KLS-Martin L.P.K253206细致入微的个性化CMF解决方案Meticuly Co., Ltd.K252246Leforte MMF 系统Jeil Medical CorporationK253373Southern 颅面 (CMF) 系统Southern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby生物可吸收固定系统；Inion CPS 1.5/2.0/2.5生物可吸收固定系统Inion OYK241314KLS Martin 口腔-Max 嵌入物 MR 条件性（捆绑）KLS-Martin L.P.
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。
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