FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Fluoride Varnish (Type A,Type C)
K Number: K253052
·
Decision Jun 11, 2026
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
137
Applicant Total
1
Review Days
262
Basic Information
- Device Name
- Fluoride Varnish (Type A,Type C)
- K Number
- K253052
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3260
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nagy Oral Technology Qinhuangdao Co., Ltd.
- Date Received
- September 22, 2025
- Decision Date
- June 11, 2026
- Product Code
- LBH
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LBH | Varnish, Cavity | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LBH), ordered by most recent decision date.
VOCO Profluorid Varnish + BioMin
FDA 510(k)
FDA Class 2
·Dental
UltraEZ
FDA 510(k)
FDA Class 2
·Dental
APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)
FDA 510(k)
FDA Class 2
·Dental
FluoroDose Varnish
FDA 510(k)
FDA Class 2
·Dental
Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3% / Cherry); Rennou Varnish (3% / Bubble Gum)
FDA 510(k)
FDA Class 2
·Dental
ReminGel
FDA 510(k)
FDA Class 2
·Dental