Fluoride Varnish (Type A,Type C)
FDA 510(k) clearance K253052 · decided 2026-06-11
Clearance details
- K-number
- K253052
- Device name
- Fluoride Varnish (Type A,Type C)
- Applicant
- Nagy Oral Technology Qinhuangdao Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-22
- Decision date
- 2026-06-11
- Days to decision
- 262 days
- Clearance type
- Traditional
- Product code
- LBH
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Qinhuangdao, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.