Manufacturer registered with FDA
Dxm Co., Ltd.
Jeonnam-Gwangju Special Metropolitan City, South Korea. Lists 12 dental device types with FDA across 1 registered establishment, and holds 6 510(k) clearances as applicant.
- Device types listed
- 12
- Brands and models
- 34
- 510(k) clearances
- 62004–2020
- Markets registered in
- 27 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2000–2026
Registered in 2 markets
Where regulators' registries name Dxm 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 | Dxm Co., Ltd. | 6 clearances | 2004–2020 | Below |
| Taiwan | TFDA | Manufacturer | DXM CO., LTD. | 7 | 2010–2015 | 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 Dxm 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 | Coltolux LED 2Cybird GoldCybird LED Curing LightCybird UltraCybird WPT LED Curing LightCybird XDD1D1 LED Curing Light SPEC 3 LED 3000D1-CL | 2007 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Lister | DXM BENDABLE/PRE-BEND NEEDLE TIPMISO | 2007 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | D6MULTIPLE names and models | 2012 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | DIBT Disposable Impression Bite TrayFishbone Hybrid Disposable Bite Tray | 2019 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | ALADDIN | 2006 |
| Anesthetic Tube WarmerEFC · Class 1 | — | Maker | C Warmer | 2008 |
| X-Ray Beam AlignerEHA · Class 1 | — | Maker | DXPAMultiple names | 2009 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | DPA110Multiple names | 2009 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | HawkIntraoral Camera and Accessories | 2007 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | DX-MIXER MIXING TIPS FOR SYRINGE, RESTORATIVE AND IMPRESSION MATERIALEZ VPS Connector | 2014 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | DX-CondenserEndopexFriendoFriendo Pen TipGutta EasyGutta Easy Needle 23GGutta Easy Needle 25G | 2008 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | DX-UltraUltrasonic Endo Activate Device | 2025 |
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 Dxm Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 10 Jan 2020 | K191221 | Cybird LED Curing Light | EBZ Ultraviolet Activator for Polymerization |
| 24 Jan 2018 | K173876 | Cybird LED Curing Light | EBZ Ultraviolet Activator for Polymerization |
| 27 Nov 2012 | K121093 | D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 | EBZ Ultraviolet Activator for Polymerization |
| 12 Sep 2008 | K081694 | DENJECTOR | EJI Cartridge Syringe |
| 12 Oct 2004 | K042703 | CYBIRD LED CURING LIGHT | EBZ Ultraviolet Activator for Polymerization |
| 20 Apr 2004 | K040116 | HAWK INTRAORAL CAMERA AND ACCESSORIES | EIA Operative Dental Unit |
Some of these clearances are listed with FDA today by another company: Xplora USA LLC (1), Coltene/Whaledent AG (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DXM CO., LTD.FDA reg. 3004082121 | Jeonnam-Gwangju Special Metropolitan City, South Korea | Complaint file establishment, Contract manufacturer, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9057162). 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.