UltraPrint-Dental 牙科临时冠桥紫外线
K号: K213643 · 2022-01-14
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决定日期2022-01-14
产品代码EBG
咨询委员会DE
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决定实质等同
器械摘要
UltraPrint-Dental Temp C&B UV is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Heygears IMC., Inc.. It received FDA 510(k) clearance on 2022-01-14 under 510(k) number K213643. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the UltraPrint-Dental Temp C&B UV?
UltraPrint-Dental Temp C&B UV is a medical device that received FDA 510(k) clearance on 2022-01-14. The listed applicant is Guangzhou Heygears IMC., Inc.. The 510(k) number is K213643.
When did UltraPrint-Dental Temp C&B UV receive FDA 510(k) clearance?
UltraPrint-Dental Temp C&B UV received FDA 510(k) clearance on 2022-01-14, under 510(k) number K213643.
Who is the listed applicant for UltraPrint-Dental Temp C&B UV?
FDA 510(k)记录将广州海格智能医疗器械有限公司列为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for UltraPrint-Dental Temp C&B UV?
The FDA product code for UltraPrint-Dental Temp C&B UV is EBG.
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。
列明Guangzhou Heygears IMC., Inc.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。
相关器械（代码：EBG）
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。
K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT 基础”和“FLNT 临时”Liaoning Upcera Co., Ltd.K251271TempFIT 临时牙冠和牙桥树脂Rizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA基牙科树脂Taiwan Dental Materials Co., Ltd.
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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