牙科屏障和套筒
K号: K250606 · 2025-05-29
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决定日期2025-05-29
产品代码PEM
咨询委员会SU
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决定实质等同
器械摘要
Dental Barrier and Sleeves is the device name listed in this FDA 510(k) record. The listed applicant is Yueying Medical Instruments (Langfang) Co., Ltd.. It received FDA 510(k) clearance on 2025-05-29 under 510(k) number K250606. The device is classified under product code PEM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Dental Barrier and Sleeves?
Dental Barrier and Sleeves is a medical device that received FDA 510(k) clearance on 2025-05-29. The listed applicant is Yueying Medical Instruments (Langfang) Co., Ltd.. The 510(k) number is K250606.
When did Dental Barrier and Sleeves receive FDA 510(k) clearance?
Dental Barrier and Sleeves received FDA 510(k) clearance on 2025-05-29, under 510(k) number K250606.
Who is the listed applicant for Dental Barrier and Sleeves?
The FDA 510(k) record lists Yueying Medical Instruments (Langfang) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dental Barrier and Sleeves?
The FDA product code for Dental Barrier and Sleeves is PEM.
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：PEM）
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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