K253052
- 510(k) number
- K253052
- Device name
- Fluoride Varnish (Type A,Type C)
- Applicant
- Nagy Oral Technology Qinhuangdao Co., Ltd. CN
- Product code
- LBH — Varnish, Cavity
- Decision date
- 2026-06-11
- Date received
- 2025-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K253052.pdf
Official FDA record: K253052
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.