FDA Registration
Active
🇺🇸 United States
Night Guard
Reg #: 3011429437
·
FEI: 3011429437
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- 3D DIAGNOSTIX INC
- Registration Number
- 3011429437
- FEI Number
- 3011429437
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 24 Denby rd, Suite 148
- City
- Allston
- State
- MA
- ZIP
- 02134
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202465
Owner / Operator
- Firm Name
- 3D Diagnostix inc
- Operator Number
- 10049937
- Address
- 24 Denby Rd, Suite 148
- City
- Allston
- State
- MA
- Postal Code
- 02134
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2024-01-02 |
Proprietary Names
Night Guard
Establishment Types
Manufacture Medical Device