FDA 510(k)

OBA-MCP，MCP正畸托槽粘合剂

K号: K173020 · 2018-01-17

决定日期2018-01-17

产品代码DYH

咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。

决定实质等同

器械摘要

OBA-MCP, Orthodontic Bracket Adhesive with MCP is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2018-01-17 under 510(k) number K173020. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OBA-MCP, Orthodontic Bracket Adhesive with MCP?

OBA-MCP, Orthodontic Bracket Adhesive with MCP is a medical device that received FDA 510(k) clearance on 2018-01-17. The listed applicant is Pulpdent Corporation. The 510(k) number is K173020.

When did OBA-MCP, Orthodontic Bracket Adhesive with MCP receive FDA 510(k) clearance?

OBA-MCP, Orthodontic Bracket Adhesive with MCP received FDA 510(k) clearance on 2018-01-17, under 510(k) number K173020.

Who is the listed applicant for OBA-MCP, Orthodontic Bracket Adhesive with MCP?

The FDA 510(k) record lists Pulpdent Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OBA-MCP, Orthodontic Bracket Adhesive with MCP?

The FDA product code for OBA-MCP, Orthodontic Bracket Adhesive with MCP is DYH.

列明Pulpdent Corporation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。

K210045ACTIVA PRESTO 包装 K172169Pulpdent (Activa) Pit and Fissure Sealant with MCP K153249Pulpdent Solo Flowable Composite with MCP

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。