FDA Registration
Active
🇹🇼 Taiwan
APOZA ENTERPRISE CO., LTD.
Reg #: 9680864
·
FEI: 1000493876
·
Expires 2026
Products
7
Proprietary Names
10
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- APOZA ENTERPRISE CO., LTD.
- Registration Number
- 9680864
- FEI Number
- 1000493876
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6F, NO.657, Chung-Cheng Road
- City
- Hsin-Chuang District New Taipei
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K041303
Owner / Operator
- Firm Name
- APOZA ENTERPRISE CO. LTD
- Operator Number
- 9012024
- Address
- 6F, NO.657, Chung-Cheng Road
- City
- Hsin-Chuang District
- State
- New Taipei
- Postal Code
- 24257
- Country
- TW
- Correspondent
- Ying Chieh Hsu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2003-08-01 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2004-10-20 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2012-02-07 |
| Light, Fiber Optic, Dental | EAY | Class 1 | Dental | No | 1994-11-30 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2014-07-29 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2012-02-07 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2006-03-31 |
Proprietary Names
LED Turbo Pen ; TOP Light Turbo ; TOP Light plus; TOP Light ; Megalight Turbo ; LED 10W ; Mega light CL
BT COOL;BT COOL (plus) ; BT COOL Easy
Oral Camera; CAM-Ⅰ; CAM-Ⅱ
Light, fiber Optic, Dental
GP Series
APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W
Selector U2 Plus,with and without Endo;Selector U2, with and without Endo
PROPHY APII
OZONEDTA;OZONYMED
LED TURBO
Establishment Types
Manufacture Medical Device