Data / Medical devices / South Korea / DXM Co., Ltd.
DXM Co., Ltd.: FDA-registered device maker in Jeonnam-Gwangju Special Metropolitan City, South Korea, 4 510(k) clearances
DXM Co., Ltd. is registered with the FDA (registration 3004082121) in Jeonnam-Gwangju Special Metropolitan City, South Korea. It lists 14 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 10, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004082121
- Address
- 102-4, Sandan-gil, Hwasun-eup, Hwasun-gun, Jeonnam-Gwangju Special Metropolitan City, South Korea, 58141
- Owner or operator
- DXM CO., LTD. (9057162)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- May 19, 2006
- Registered through
- 2027
- Brand names listed
- ALADDIN, Blade-Safe Scalpel Blade Remover, C Warmer, Coltolux LED 2, Cybird Gold, Cybird LED Curing Light, Cybird Ultra, Cybird WPT LED Curing Light and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Manufacturer | accessdata.fda.gov |
| Aligner, Beam, X-Ray | EHA | 1 | Manufacturer | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Manufacturer | accessdata.fda.gov |
| Cup, Prophylaxis | EHK | 1 | Manufacturer | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Manufacturer | accessdata.fda.gov |
| Light, Operating, Dental | EAZ | 1 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Manufacturer | accessdata.fda.gov |
| Plugger, Root Canal, Endodontic | EKR | 1 | Manufacturer | accessdata.fda.gov |
| Protector, Dental | BRW | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | Manufacturer | accessdata.fda.gov |
| Warmer, Anesthetic Tube | EFC | 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 |
|---|---|---|---|---|---|---|
| January 10, 2020 | K191221 | Cybird LED Curing Light | EBZ | Substantially Equivalent | Dxm Co., Ltd. | accessdata.fda.gov |
| November 27, 2012 | K121093 | D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 | EBZ | Substantially Equivalent | Dxm Co., Ltd. | accessdata.fda.gov |
| October 12, 2004 | K042703 | CYBIRD LED CURING LIGHT | EBZ | Substantially Equivalent | Dxm Co., Ltd. | accessdata.fda.gov |
| April 20, 2004 | K040116 | HAWK INTRAORAL CAMERA AND ACCESSORIES | EIA | Substantially Equivalent | Dxm Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Impression Tray, Resin
- All makers of Protector, Dental
- All makers of Activator, Ultraviolet, For Polymerization
- All makers of Light, Operating, Dental
- All makers of Needle, Dental
- All makers of Blade, Scalpel
Updated January 10, 2020. 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.