FDA Registration
Active
🇺🇸 United States
NDX Paramount Dental Laboratory
Reg #: 3012690648
·
FEI: 3012690648
·
Expires 2026
Products
10
Proprietary Names
9
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- NDX Paramount Dental Laboratory
- Registration Number
- 3012690648
- FEI Number
- 3012690648
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1851 Heritage Lane, Ste 148
- City
- Sacramento
- State
- CA
- ZIP
- 95815
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191986
Owner / Operator
- Firm Name
- National Dentex LLC
- Operator Number
- 9052467
- Address
- 4400 PGA Blvd, Suite 700
- City
- Palm Beach Gardens
- State
- FL
- Postal Code
- 33410
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2026-02-10 |
| Restoration, Porcelain | NSP | Class N | Unknown | No | 2008-02-01 |
| Restoration, Noble Metal | NSJ | Class N | Unknown | No | 2008-02-01 |
| Dental Abutment Design Software For Dental Laboratory | PNP | Class 2 | Dental | No | 2026-02-10 |
| Dentures, Partial | NSK | Class N | Unknown | No | 2008-02-01 |
| Restoration, Porcelain-Fused-To-Metal | NSO | Class N | Unknown | No | 2008-02-01 |
| Restoration, Base Metal | NSQ | Class N | Unknown | No | 2008-02-01 |
| Dentures, Full | NSL | Class N | Unknown | No | 2008-02-01 |
| Restoration, Resin, Crown And Bridge | NSN | Class N | Unknown | No | 2008-02-01 |
| Prosthesis, Orthodontic | NSR | Class N | Unknown | No | 2008-02-01 |
Proprietary Names
DESS Ti Base Abutments
Restoration, porcelain
Restoration, noble metal
Dentures, partial
Restoration, porcelain-fused-to-metal
Restoration, base metal
Dentures, full
Restoration, resin, crown and bridge
Prosthesis, orthodontic
Establishment Types
Repack or Relabel Medical Device