FDA Registration
Active
🇺🇸 United States
CS 3600
Reg #: 1226003
·
FEI: 3002522649
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Carestream Dental LLC
- Registration Number
- 1226003
- FEI Number
- 3002522649
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3625 Cumberland Boulevard, Suite 700
- City
- Atlanta
- State
- GA
- ZIP
- 30339
- Country
- US
Owner / Operator
- Firm Name
- Carestream Dental LLC
- Operator Number
- 10056540
- Address
- 3625 Cumberland Boulevard, Suite 700
- City
- Atlanta
- State
- GA
- Postal Code
- 30339
- Country
- US
- Correspondent
- Raven Wildharber
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2019-02-13 |
Proprietary Names
CS 3600
Trophy 3DI Beyond
Trophy 3DI Pro
CS 3700
CS 3600 Access
Trophy 3800 Wireless
CS 3800 Wireless
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198