Manufacturer registered with FDA
Monitex Industrial Co., Ltd.
NEW TAIPEI CITY, Taiwan. Lists 6 dental device types with FDA across 1 registered establishment, and holds 9 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 10
- 510(k) clearances
- 92005–2017
- Markets registered in
- 318 registrations outside the US
- Establishments
- 1Taiwan
510(k) clearances per year, 2000–2026
Registered in 3 markets
Where regulators' registries name Monitex Industrial 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 | Monitex Industrial Co., Ltd. | 9 clearances | 2005–2017 | Below |
| South Korea | MFDS | Manufacturer | MONITEX INDUSTRIAL CO., LTD.Monitex Industrial Co Ltd. · Monitex Industrial Co., Ltd. · +2 | 17 | 2002–2013 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Monitex Industrial 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 Monitex Industrial 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 | DarbyHenry ScheinMaxima Advanced 3000 LED Curing Light | 2007 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | Henry ScheinWE Light Class II | 2009 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Henry Schein | 2012 |
| Ac-Powered Dental AmalgamatorEFD · Class 1 | — | Maker | Henry ScheinSHOFU DENTAL CORPORATION | 2009 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Kerr | 2020 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | HPR Cordless Hygiene Handpiece | 2026 |
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 Monitex Industrial Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 27 Nov 2017 | K161855 | LED Curing Light | EBZ Ultraviolet Activator for Polymerization |
| 7 Apr 2017 | K152192 | LED Curing Light | EBZ Ultraviolet Activator for Polymerization |
| 28 Jun 2016 | K153078 | LED Curing Light GT-2000 | EBZ Ultraviolet Activator for Polymerization |
| 24 Aug 2015 | K150205 | LED Curing Light | EBZ Ultraviolet Activator for Polymerization |
| 7 Oct 2014 | K133040 | LED CURING LIGHT | EBZ Ultraviolet Activator for Polymerization |
| 18 Sep 2009 | K091887 | LED CURING LIGHT, MODEL GT-1500 | EBZ Ultraviolet Activator for Polymerization |
| 3 Mar 2008 | K080035 | LED CURING LIGHT | EBZ Ultraviolet Activator for Polymerization |
| 21 Apr 2006 | K060646 | BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 | EBZ Ultraviolet Activator for Polymerization |
| 25 May 2005 | K051203 | BLUELEX | EBZ Ultraviolet Activator for Polymerization |
Some of these clearances are listed with FDA today by another company: Peter Brasseler Holdings, LLC (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MONITEX INDUSTRIAL CO., LTD.FDA reg. 3003169405 | SAN-CHUNG CITY Taipei, Taiwan | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9044777). 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.