510(k) K253052
K253052 is an FDA 510(k) premarket notification submitted by Nagy Oral Technology Qinhuangdao Co., Ltd. for the device "Fluoride Varnish (Type A,Type C)". The FDA issued a decision of Substantially Equivalent on June 11, 2026. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 2026
- Date Received
- September 22, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Varnish, Cavity
- Device Class
- Class II
- Regulation Number
- 872.3260
- Review Panel
- DE
- Submission Type