FDA Registration
Active
🇺🇸 United States
DENTLIGHT INC.
Reg #: 3005515469
·
FEI: 3005515469
·
Expires 2026
Products
10
Proprietary Names
12
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- DENTLIGHT INC.
- Registration Number
- 3005515469
- FEI Number
- 3005515469
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1825 Summit Ave Ste 210
- City
- Plano
- State
- TX
- ZIP
- 75074
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201387
Owner / Operator
- Firm Name
- DENTLIGHT INC.
- Operator Number
- 9077801
- Address
- 1825 Summit Ave., SUITE 210
- City
- Plano
- State
- TX
- Postal Code
- 75074
- Country
- US
- Correspondent
- RICHARD - LIU
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laser, Dental, Soft Tissue | NVK | Class 2 | General, Plastic Surgery | No | 2021-04-01 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2021-04-01 |
| Loupe, Diagnostic/Surgical | FSP | Class 1 | General, Plastic Surgery | No | 2009-01-16 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2021-04-01 |
| Light, Surgical Headlight | EBA | Class 1 | Dental | No | 2007-12-10 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2010-02-04 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2005-12-19 |
| Diagnostic Light, Soft Tissue Detector | NXV | Class 2 | Dental | No | 2010-07-18 |
| Detector, Ultraviolet | EAQ | Class 2 | Dental | No | 2010-07-18 |
| Camera, Television, Surgical, With Audio | FWC | Class 1 | General, Plastic Surgery | No | 2016-05-22 |
Proprietary Names
Ultrafast
iZoom Loupes
FUSION PBM
iZoom
Nano Loupe Light
FUSION Curing Light
DOE
DOE SE
FUSION-DOE
Dentlight Oral Exam Light Kit
FUSION Plus-Grand Curing Light
iOCam
Establishment Types
Manufacture Medical Device
Remanufacture Medical Device