K231060
- 510(k) number
- K231060
- Device name
- ProMin Dental Desensitizing Gel
- Applicant
- Belport Company, Inc., Gingi-Pak CA · US
- Product code
- LBH — Varnish, Cavity
- Decision date
- 2024-06-13
- Date received
- 2023-04-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K231060
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.