瓷器刻蚀凝胶
K号: K260430 · 2026-04-10
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决定日期2026-04-10
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
Porcelain Etch Gel is the device name listed in this FDA 510(k) record. The listed applicant is Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K260430. 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 Porcelain Etch Gel?
Porcelain Etch Gel is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Belport Company, Inc., Gingi-Pak. The 510(k) number is K260430.
When did Porcelain Etch Gel receive FDA 510(k) clearance?
Porcelain Etch Gel received FDA 510(k) clearance on 2026-04-10, under 510(k) number K260430.
Who is the listed applicant for Porcelain Etch Gel?
The FDA 510(k) record lists Belport Company, Inc., Gingi-Pak as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Porcelain Etch Gel?
The FDA product code for Porcelain Etch Gel is KLE.
相关临床试验
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列明Belport Company, Inc., Gingi-Pak为申报人的其他记录
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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