FDA Registration
Active
🇺🇸 United States
OTC DENTAL
Reg #: 3013425656
·
FEI: 3013425656
·
Expires 2026
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OTC DENTAL
- Registration Number
- 3013425656
- FEI Number
- 3013425656
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3825 W Cheyenne Ave Ste 606
- City
- N Las Vegas
- State
- NV
- ZIP
- 89032
- Country
- US
Regulatory Submissions
- 510(k) Number
- K974865
Owner / Operator
- Firm Name
- OTC Dental
- Operator Number
- 10053689
- Address
- 3825 W Cheyenne Ave, Ste 606
- City
- North Las Vegas
- State
- NV
- Postal Code
- 89032
- Country
- US
- Correspondent
- Steven M Delepine
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2026-01-15 |
Proprietary Names
DenSureFit
DenSureFitPro
Establishment Types
Repack or Relabel Medical Device