FDA Registration
Active
🇺🇸 United States
ADDENT, INC.
Reg #: 3003694926
·
FEI: 3003694926
·
Expires 2026
Products
10
Proprietary Names
18
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- ADDENT, INC.
- Registration Number
- 3003694926
- FEI Number
- 3003694926
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 43 Miry Brook Rd
- City
- DANBURY
- State
- CT
- ZIP
- 06810
- Country
- US
Regulatory Submissions
- 510(k) Number
- K061395
Owner / Operator
- Firm Name
- ADDENT, INC.
- Operator Number
- 9053384
- Address
- 43 MIRY BROOK RD., --
- City
- Danbury
- State
- CT
- Postal Code
- 06810
- Country
- US
- Correspondent
- JOSHUA - FRIEDMAN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2009-04-16 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2009-04-16 |
| Warmer, Anesthetic Tube | EFC | Class 1 | Dental | No | 2009-04-16 |
| Transilluminator, Battery-Powered | HJN | Class 1 | Ophthalmic | No | 2002-10-16 |
| Composite Resin Warmer | QGO | Class 1 | Dental | No | 2021-02-26 |
| Light, Operating, Dental | EAZ | Class 1 | Dental | No | 2009-04-16 |
| Diagnostic Light, Soft Tissue Detector | NXV | Class 2 | Dental | No | 2014-12-30 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2009-04-16 |
| Caries Detector, Laser Light, Transmission | NTK | Class 2 | Dental | No | 2009-04-16 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2002-10-16 |
Proprietary Names
Calset Composite Warmer
Calset Aluminum Accessory Trays
MICROLUX 2
MICROLUX DW
MICROLUX MINI
MICROLUX
Compex HD
Rite-Lite
Rite-Lite 2
Rite-Lite PRO
Bio/Screen
CoMax
Microlux Transilluminator
Microlux 2 Transilluminator
Microlux Mini Transilluminator
Microlux DW Transilluminator
VAC-TAK
TRIMAX
Establishment Types
Manufacture Medical Device