FDA Registration
Active
🇺🇸 United States
PROEDGE DENTAL PRODUCTS
Reg #: 3009161303
·
FEI: 3009161303
·
Expires 2026
Products
4
Proprietary Names
4
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- PROEDGE DENTAL PRODUCTS
- Registration Number
- 3009161303
- FEI Number
- 3009161303
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 10730 E Briarwood Ave
- City
- Centennial
- State
- CO
- ZIP
- 80112
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232393
Owner / Operator
- Firm Name
- ProEdge Dental Products
- Operator Number
- 9045179
- Address
- 10730 E Briarwood Ave
- City
- Centennial
- State
- CO
- Postal Code
- 80112
- Country
- US
- Correspondent
- MARK - FRAMPTON
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dental Waterline Treatment Cartridge | QYJ | Class 1 | Dental | No | 2024-05-28 |
| Unit, Operative Dental | EIA | Class 1 | Dental | No | 2024-05-28 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2006-09-01 |
| Holder, Film, X-Ray | EGZ | Class 1 | Dental | No | 2009-04-06 |
Proprietary Names
BluTube
BluTab Waterline Maintenance Tablets
BluTube Dental Unit Water Purification Cartridge
SoftX Foam Digital Sensor Loops
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)