FDA Registration
Active
🇨🇦 Canada
PROTO3000 INC.
Reg #: 3013343038
·
FEI: 3013343038
·
Expires 2026
Products
7
Proprietary Names
5
Establishment Types
1
Classifications
7
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Registration Details
- Registration Name
- PROTO3000 INC.
- Registration Number
- 3013343038
- FEI Number
- 3013343038
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6260 Highway 7, Unit 8
- City
- Vaughan Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K123220
Owner / Operator
- Firm Name
- Proto3000 Inc.
- Operator Number
- 10086557
- Address
- 6260 Highway 7, Unit 8
- City
- Vaughan
- State
- Ontario
- Postal Code
- L4H4G3
- Country
- CA
- Correspondent
- Louie Canitano
US Agent
- Business Name
- Medical Devices International
- Contact Name
- Lawerence Petersen
- Address
- 4241 Wildwood Lndg
- City
- N Charleston
- State
- SC
- ZIP
- 29420
- Country
- US
- [email protected]
- Phone
- 303 4892500
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2023-08-16 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2023-08-16 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2023-08-16 |
| Dental Abutment Design Software For Dental Laboratory | PNP | Class 2 | Dental | No | 2023-08-16 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2023-08-16 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2023-08-16 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2023-08-16 |
Proprietary Names
Vertex-Dental B.V.
Medit Scanner
Dental Direkt GmbH
Upcera
Exocad Exoplan
Establishment Types
Manufacture Medical Device