Tatum 手术牙种植系统
K号: K213576 · 2022-07-15
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决定日期2022-07-15
产品代码DZE
咨询委员会DE
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器械摘要
Tatum Surgical Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Suncoast Dental, Inc. Dba Tatum Surgical. It received FDA 510(k) clearance on 2022-07-15 under 510(k) number K213576. 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 Tatum Surgical Dental Implant System?
Tatum Surgical Dental Implant System is a medical device that received FDA 510(k) clearance on 2022-07-15. The listed applicant is Suncoast Dental, Inc. Dba Tatum Surgical. The 510(k) number is K213576.
When did Tatum Surgical Dental Implant System receive FDA 510(k) clearance?
Tatum Surgical Dental Implant System received FDA 510(k) clearance on 2022-07-15, under 510(k) number K213576.
Who is the listed applicant for Tatum Surgical Dental Implant System?
The FDA 510(k) record lists Suncoast Dental, Inc. Dba Tatum Surgical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tatum Surgical Dental Implant System?
The FDA product code for Tatum Surgical Dental Implant System is DZE.
相关临床试验
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相关器械（代码：DZE）
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。
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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