3M Clinpro Clear 2.1% Sodium Fluoride Treatment
FDA 510(k) K231338 · 3M Espe Dental Products
510(k) numberK231338
Submission
- Device name
- 3M Clinpro Clear 2.1% Sodium Fluoride Treatment
- Applicant
- 3M Espe Dental Products
Saint Paul, MN, US - Received
- May 8, 2023
- Decision date
- May 10, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was 3M Clinpro Clear 2.1% Sodium Fluoride Treatment cleared by the FDA?
3M Clinpro Clear 2.1% Sodium Fluoride Treatment (K231338) received a 510(k) decision of Substantially Equivalent on May 10, 2023, 2 days after the submission was received.
What is the product code of K231338?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.