FDA Registration
Active
🇺🇸 United States
FRESH Bold Impression Material
Reg #: 1836392
·
FEI: 3003136707
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- EXACTA DENTAL PRODUCTS, INC.
- Registration Number
- 1836392
- FEI Number
- 3003136707
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 44780 MACOMB INDUSTRIAL DR.
- City
- CLINTON TOWNSHIP
- State
- MI
- ZIP
- 48036
- Country
- US
Regulatory Submissions
- 510(k) Number
- K053427
Owner / Operator
- Firm Name
- EXACTA DENTAL PRODUCTS, INC.
- Operator Number
- 9043538
- Address
- 44780 MACOMB INDUSTRIAL DR., --
- City
- CLINTON TOWNSHIP
- State
- MI
- Postal Code
- 48036
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Impression | ELW | Class 2 | Dental | No | 2009-01-23 |
Proprietary Names
FRESH Bold Impression Material
Establishment Types
Repack or Relabel Medical Device