FDA 510(k)

3M Clinpro Clear 2.1% Sodium Fluoride Treatment

K-Number: K231338 · 2023-05-10

Decision Date2023-05-10

Product CodeLBH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by 3M Espe Dental Products. The 510(k) number is K231338.

When was 3M Clinpro Clear 2.1% Sodium Fluoride Treatment approved by the FDA?

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

What company makes 3M Clinpro Clear 2.1% Sodium Fluoride Treatment?

3M Clinpro Clear 2.1% Sodium Fluoride Treatment is manufactured by 3M Espe Dental Products.

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.