FDA Registration
Active
🇺🇸 United States
Xplora USA LLC
Reg #: 3008882689
·
FEI: 3008882689
·
Expires 2026
Products
24
Proprietary Names
2
Establishment Types
3
Classifications
24
Registration Details
- Registration Name
- Xplora USA LLC
- Registration Number
- 3008882689
- FEI Number
- 3008882689
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1501 Randolph St, Ste K16
- City
- Carrollton
- State
- TX
- ZIP
- 75006
- Country
- US
Regulatory Submissions
- 510(k) Number
- K131734
Owner / Operator
- Firm Name
- Xplora USA LLC
- Operator Number
- 10089697
- Address
- 1501 Randolph St, Ste K16
- City
- Carrollton
- State
- TX
- Postal Code
- 75006
- Country
- US
- Correspondent
- Bruce Page
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2024-01-08 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2024-01-08 |
| Instrument, Cutting, Operative | EKD | Class 1 | Dental | No | 2024-01-08 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2024-01-08 |
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | Class 2 | Dental | No | 2024-01-08 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2024-01-08 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2024-01-08 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2024-01-08 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2024-01-08 |
| Teeth, Artificial, Backing And Facing | ELK | Class 1 | Dental | No | 2024-02-28 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2024-01-08 |
| Indirect Bonding Tray | QJJ | Class 1 | Dental | No | 2024-01-08 |
| Bracket, Plastic, Orthodontic | DYW | Class 2 | Dental | No | 2024-01-08 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2024-01-08 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2024-01-08 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2024-01-08 |
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2023-12-29 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2024-01-08 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 2024-01-08 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2024-01-08 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2024-01-08 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2024-01-08 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2024-01-08 |
| Instrument, Diamond, Dental | DZP | Class 1 | Dental | No | 2024-01-08 |
Proprietary Names
Six Month Smiles
Lammina
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198