Minitube Dentasleeve保护屏障套筒
K号: K211026 · 2021-08-03
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器械摘要
Minitube Dentasleeve Protective Barrier Sleeves is the device name listed in this FDA 510(k) record. The listed applicant is Minitube AB. It received FDA 510(k) clearance on 2021-08-03 under 510(k) number K211026. 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 Minitube Dentasleeve Protective Barrier Sleeves?
Minitube Dentasleeve Protective Barrier Sleeves is a medical device that received FDA 510(k) clearance on 2021-08-03. The listed applicant is Minitube AB. The 510(k) number is K211026.
When did Minitube Dentasleeve Protective Barrier Sleeves receive FDA 510(k) clearance?
Minitube Dentasleeve Protective Barrier Sleeves received FDA 510(k) clearance on 2021-08-03, under 510(k) number K211026.
Who is the listed applicant for Minitube Dentasleeve Protective Barrier Sleeves?
The FDA 510(k) record lists Minitube AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Minitube Dentasleeve Protective Barrier Sleeves?
The FDA product code for Minitube Dentasleeve Protective Barrier Sleeves is PEM.
相关临床试验
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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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