Data / Medical devices / Taiwan / Apoza Enterprise Co., Ltd.
Apoza Enterprise Co., Ltd.: FDA-registered device maker in Hsin-Chuang District New Taipei, Taiwan, 4 510(k) clearances
Apoza Enterprise Co., Ltd. is registered with the FDA (registration 9680864) in Hsin-Chuang District New Taipei, Taiwan. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 2, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680864
- FEI number
- 1000493876
- Address
- 6F, NO.657, Chung-Cheng Road, Hsin-Chuang District New Taipei, Taiwan, 24257
- Owner or operator
- APOZA ENTERPRISE CO. LTD (9012024)
- Roles
- Manufacturer
- First device listed
- November 30, 1994
- Registered through
- 2026
- Brand names listed
- APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W, BT COOL;BT COOL (plus) ; BT COOL Easy, GP Series, LED TURBO, LED Turbo Pen ; TOP Light Turbo ; TOP Light plus; TOP Light ; Megalight Turbo ; LED 10W ; Mega light CL, Light, fiber Optic, Dental, OZONEDTA;OZONYMED, Oral Camera; CAM-Ⅰ; CAM-Ⅱ and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Manufacturer | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Manufacturer | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Manufacturer | accessdata.fda.gov |
| Light, Fiber Optic, Dental | EAY | 1 | Manufacturer | accessdata.fda.gov |
| Plugger, Root Canal, Endodontic | EKR | 1 | Manufacturer | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 2, 2007 | K070373 | APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W | EBZ | Substantially Equivalent | Apoza Enterprise Co., Ltd. | accessdata.fda.gov |
| June 18, 2004 | K041303 | LED TURBO-PEN | EBZ | Substantially Equivalent | Apoza Enterprise Co., Ltd. | accessdata.fda.gov |
| April 30, 2004 | K033198 | APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2 | ELC | Substantially Equivalent | Apoza Enterprise Co., Ltd. | accessdata.fda.gov |
| March 25, 2004 | K040618 | LED TURBO | EBZ | Substantially Equivalent | Apoza Enterprise Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Activator, Ultraviolet, For Polymerization
- All makers of Disinfectant, Medical Devices
- All makers of Light, Fiber Optic, Dental
- All makers of Unit, Operative Dental, Accessories
- All makers of Scaler, Ultrasonic
- All makers of Heat Source For Bleaching Teeth
Updated March 2, 2007. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.