ProMin Dental Desensitizing Gel
FDA 510(k) K231060 · Belport Company, Inc., Gingi-Pak
510(k) numberK231060
Submission
- Device name
- ProMin Dental Desensitizing Gel
- Applicant
- Belport Company, Inc., Gingi-Pak
Camarillo, CA, US - Received
- April 13, 2023
- Decision date
- June 13, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was ProMin Dental Desensitizing Gel cleared by the FDA?
ProMin Dental Desensitizing Gel (K231060) received a 510(k) decision of Substantially Equivalent on June 13, 2024, 427 days after the submission was received.
What is the product code of K231060?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.