FDA 510(k)

3M® Clinpro® Clear 2.1% Sodium Fluoride Treatment

K号: K231338 · 2023-05-10

决定日期2023-05-10

产品代码LBH

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决定实质等同

器械摘要

3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment is the device name listed in this FDA 510(k) record. The listed applicant is 3M Espe Dental Products. It received FDA 510(k) clearance on 2023-05-10 under 510(k) number K231338. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment?

3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment is a medical device that received FDA 510(k) clearance on 2023-05-10. The listed applicant is 3M Espe Dental Products. The 510(k) number is K231338.

When did 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment receive FDA 510(k) clearance?

3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment received FDA 510(k) clearance on 2023-05-10, under 510(k) number K231338.

Who is the listed applicant for 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment?

The FDA 510(k) record lists 3M Espe Dental Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment?

The FDA product code for 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment is LBH.

列明3M Espe Dental Products为申报人的其他记录

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