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K号: K242646 · 2025-04-11
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决定日期2025-04-11
产品代码EBW
咨询委员会DE
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器械摘要
Dental Implant Unit is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Aesthedent Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K242646. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Dental Implant Unit?
Dental Implant Unit is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Guilin Aesthedent Medical Instruments Co., Ltd.. The 510(k) number is K242646.
When did Dental Implant Unit receive FDA 510(k) clearance?
Dental Implant Unit received FDA 510(k) clearance on 2025-04-11, under 510(k) number K242646.
Who is the listed applicant for Dental Implant Unit?
The FDA 510(k) record lists Guilin Aesthedent Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dental Implant Unit?
The FDA product code for Dental Implant Unit is EBW.
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：EBW）
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。
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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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