FDA Registration
Active
🇺🇸 United States
DENTAL PLUS USA, LLC
Reg #: 3027494823
·
FEI: 3027494823
·
Expires 2026
Products
7
Proprietary Names
4
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- DENTAL PLUS USA, LLC
- Registration Number
- 3027494823
- FEI Number
- 3027494823
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1188 West 10400 South
- City
- South Jordan
- State
- UT
- ZIP
- 84095
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200188
Owner / Operator
- Firm Name
- Dental Plus USA, LLC
- Operator Number
- 10088429
- Address
- 1188 West 10400 South
- City
- South Jordan
- State
- UT
- Postal Code
- 84095
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2025-01-28 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2025-01-28 |
| Material, Impression | ELW | Class 2 | Dental | No | 2025-01-28 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2025-01-28 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2025-01-28 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2025-01-28 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2025-01-28 |
Proprietary Names
Multi-Unit Analog, Screw, Abutment
Silicone gingival mask
PMMA
G-CAM
Establishment Types
Repack or Relabel Medical Device
Reprocess Single-Use Device