FDA Registration
Active
🇺🇸 United States
AXIODENT INC.
Reg #: 3032312561
·
FEI: 3032312561
·
Expires 2026
Products
12
Proprietary Names
14
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- AXIODENT INC.
- Registration Number
- 3032312561
- FEI Number
- 3032312561
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 501 Silverside Rd Ste 105 # 5086
- City
- Wilmington
- State
- DE
- ZIP
- 19809
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213244
Owner / Operator
- Firm Name
- Axiodent Inc.
- Operator Number
- 10091372
- Address
- 501 Silverside Rd Suite 105 #5086
- City
- Wilmington
- State
- DE
- Postal Code
- 19809
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Impression | ELW | Class 2 | Dental | No | 2024-09-09 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2025-01-05 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2025-01-05 |
| Liner, Cavity, Calcium Hydroxide | EJK | Class 2 | Dental | No | 2024-09-09 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2024-09-22 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2024-09-10 |
| Zinc Oxide Eugenol | EMB | Class 1 | Dental | No | 2024-09-10 |
| Resin, Root Canal Filling | KIF | Class 2 | Dental | No | 2024-09-09 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2024-09-29 |
| Plate, Base, Shellac | EEA | Class 1 | Dental | No | 2024-09-29 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2024-09-09 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2024-09-09 |
Proprietary Names
Axio-3D Model Pro
Axio-3D Burn Out
Axio-3D Surgical Guide
AxioShine Fresh Mint
AxioShine Fresh Fruit
AxioShine Fresh Strawberry
AxioShine Fresh Orange
AxioGloss
AxioShine Fresh Pineapple
AxioIRM XS
AxioZi-Temp
AxioIRM
AxioModelling Wax
AxioBase
Establishment Types
Repack or Relabel Medical Device