Manufacturer registered with FDA
Apoza Enterprise Co., Ltd.
Hsin-Chuang District, Taiwan. Lists 6 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 10
- 510(k) clearances
- 52003–2007
- Markets registered in
- 538 registrations outside the US
- Establishments
- 1Taiwan
510(k) clearances per year, 2000–2026
Registered in 5 markets
Where regulators' registries name Apoza Enterprise Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Apoza Enterprise Co., Ltd. | 5 clearances | 2003–2007 | Below |
| Canada | Health Canada | Registration holder | APOZA ENTERPRISE CO., LTD. | 16 | 2007–2012 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Apoza Enterprise Co., Ltd.APOZA ENTERPRISE CO., LTD · APOZA ENTERPRISE CO., LTD. · +2 | 16 | 2001–2018 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | APOZA ENTERPRISE CO., LTD. | 5 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Apoza Enterprise Co.Ltd. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Apoza Enterprise Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5WLED TURBOLED Turbo Pen ; TOP Light Turbo ; TOP Light plus; TOP Light ; Megalight Turbo ; LED 10W ; Mega light CL | 2003 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | BT COOL;BT COOL (plus) ; BT COOL EasyLED TURBO | 2003 |
| Dental Fiber Optic LightEAY · Class 1 | Dental operating lights | Maker | Light, fiber Optic, Dental | 1994 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | GP Series | 2014 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | PROPHY APIISelector U2 Plus,with and without Endo;Selector U2, with and without Endo | 2012 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Oral Camera; CAM-Ⅰ; CAM-Ⅱ | 2012 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Apoza Enterprise Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 2 Mar 2007 | K070373 | APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W | EBZ Ultraviolet Activator for Polymerization |
| 18 Jun 2004 | K041303 | LED TURBO-PEN | EBZ Ultraviolet Activator for Polymerization |
| 30 Apr 2004 | K033198 | APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2 | ELC Ultrasonic Scaler |
| 25 Mar 2004 | K040618 | LED TURBO | EBZ Ultraviolet Activator for Polymerization |
| 2 Dec 2003 | K033201 | LA500 BLUE LIGHT | EBZ Ultraviolet Activator for Polymerization |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| APOZA ENTERPRISE CO., LTD.FDA reg. 9680864 | Hsin-Chuang District New Taipei, Taiwan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9012024). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.