FDA Registration
Active
🇺🇸 United States
DIGISMILES LAB
Reg #: 3035335007
·
FEI: 3035335007
·
Expires 2026
Products
8
Proprietary Names
8
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- DIGISMILES LAB
- Registration Number
- 3035335007
- FEI Number
- 3035335007
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 219 N Second st, Suite #200
- City
- Philipsburg
- State
- PA
- ZIP
- 16866
- Country
- US
Regulatory Submissions
- 510(k) Number
- K935041
Owner / Operator
- Firm Name
- DigiSmiles Lab
- Operator Number
- 10092397
- Address
- 220 Oakwood Dr
- City
- Philipsburg
- State
- PA
- Postal Code
- 16866
- Country
- US
- Correspondent
- Alexander Boumerhi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Alloy, Other Noble Metal | EJS | Class 2 | Dental | No | 2025-01-02 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2025-01-02 |
| Teeth, Artificial, Posterior With Metal Insert | ELJ | Class 1 | Dental | No | 2025-01-02 |
| Alloy, Metal, Base | EJH | Class 2 | Dental | No | 2025-01-02 |
| Clasp, Wire | EJW | Class 1 | Dental | No | 2025-01-02 |
| Crown, Preformed | ELZ | Class 1 | Dental | No | 2025-01-02 |
| Alloy, Gold-Based Noble Metal | EJT | Class 2 | Dental | No | 2025-01-02 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2025-01-02 |
Proprietary Names
Alloy, Other Noble Metal
temporary crown
Teeth, Artificial, POSTERIOR with Metal Insert
Alloy, Metal, Base
Clasp Wire
Crown Preformed
Alloy, Gold-based Noble Metal
Retainer Screw Expansion Orthodontic
Establishment Types
Repack or Relabel Medical Device