FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
VOCO Profluorid Varnish + BioMin
K Number: K252073
·
Decision May 1, 2026
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
137
Applicant Total
119
Review Days
303
Basic Information
- Device Name
- VOCO Profluorid Varnish + BioMin
- K Number
- K252073
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3260
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Voco GmbH
- Date Received
- July 2, 2025
- Decision Date
- May 1, 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.
Fluoride Varnish (Type A,Type C)
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
Other Clearances by Voco GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K261357 | Grandio disc multicolor | Apr 27, 2026 | Substantially Equivalent |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-In | Mar 20, 2026 | Substantially Equivalent |
| K251390 | MTA vpt | Jul 3, 2025 | Substantially Equivalent |
| K251239 | GrandioSO Unlimited | May 21, 2025 | Substantially Equivalent |
| K231817 | AlignerFlow LC | Dec 1, 2023 | Substantially Equivalent |
| K231591 | V-Print c&b temp | Jul 31, 2023 | Substantially Equivalent |
| K230877 | Admira Fusion 5 | Jul 13, 2023 | Substantially Equivalent |
| K220236 | V-Print dentbase | Sep 21, 2022 | Substantially Equivalent |
| K220640 | Bifix Hybrid Abutment Cement | Aug 23, 2022 | Substantially Equivalent |
| K220743 | CediTEC | Jul 5, 2022 | Substantially Equivalent |