FDA 510(k)

LOOP LED Curing Light System

K号: K200775 · 2020-08-14

决定日期2020-08-14

产品代码EBZ

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决定实质等同

器械摘要

LOOP LED Curing Light System is the device name listed in this FDA 510(k) record. The listed applicant is Garrison Dental Solutions, LLC. It received FDA 510(k) clearance on 2020-08-14 under 510(k) number K200775. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LOOP LED Curing Light System?

LOOP LED Curing Light System is a medical device that received FDA 510(k) clearance on 2020-08-14. The listed applicant is Garrison Dental Solutions, LLC. The 510(k) number is K200775.

When did LOOP LED Curing Light System receive FDA 510(k) clearance?

LOOP LED Curing Light System received FDA 510(k) clearance on 2020-08-14, under 510(k) number K200775.

Who is the listed applicant for LOOP LED Curing Light System?

The FDA 510(k) record lists Garrison Dental Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOOP LED Curing Light System?

The FDA product code for LOOP LED Curing Light System is EBZ.

列明Garrison Dental Solutions, LLC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。

K241238LOOP™ LED Curing Light System (CLK01)

官方来源

在 FDA 数据库中查看 →

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