DX. Bond V Dental Bonding Adhesive
K号: K232978 · 2023-09-22
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决定日期2023-09-22
产品代码KLE
咨询委员会DE
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决定实质等同
器械摘要
DX. Bond V Dental Bonding Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Sino-Dentex Co., Ltd.. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K232978. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DX. Bond V Dental Bonding Adhesive?
DX. Bond V Dental Bonding Adhesive is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Sino-Dentex Co., Ltd.. The 510(k) number is K232978.
When did DX. Bond V Dental Bonding Adhesive receive FDA 510(k) clearance?
DX. Bond V Dental Bonding Adhesive received FDA 510(k) clearance on 2023-09-22, under 510(k) number K232978.
Who is the listed applicant for DX. Bond V Dental Bonding Adhesive?
The FDA 510(k) record lists Sino-Dentex Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DX. Bond V Dental Bonding Adhesive?
The FDA product code for DX. Bond V Dental Bonding Adhesive is KLE.
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：KLE）
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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