FDA Registration
Active
🇨🇦 Canada
DP-Repair
Reg #: 9613743
·
FEI: 3002856975
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DENPLUS, INC.
- Registration Number
- 9613743
- FEI Number
- 3002856975
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 333-M Chemin du Tremblay
- City
- Boucherville Quebec
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K991996
Owner / Operator
- Firm Name
- DENPLUS, INC.
- Operator Number
- 9038235
- Address
- 333-M Chemin du Tremblay, --
- City
- Boucherville
- State
- Quebec
- Postal Code
- J4B 7M1
- Country
- CA
- Correspondent
- DENIS - NOEL
US Agent
- Business Name
- Pragmatic Compliance dba FDAbasics
- Contact Name
- Jerry Doane
- Address
- 15815 SW 11th Court Rd
- City
- Ocala
- State
- FL
- ZIP
- 34473
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2016-09-21 |
Proprietary Names
DP-Repair
Impact-Plus
DP97
Impact-20
DP-HC
DP-Pour
DP20
20 minutes
Establishment Types
Manufacture Medical Device