Data / Medical devices / South Korea / Kwang Myung Daicom Ltd.
Kwang Myung Daicom Ltd.: FDA-registered device maker in Seoul, South Korea, 1 510(k) clearance
Kwang Myung Daicom Ltd. is registered with the FDA (registration 3004077103) in Seoul, South Korea. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 3, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004077103
- Address
- 5f E Plaza Bldg 253 Namdaenumro, Seoul, South Korea, 100-161
- Owner or operator
- KWANG MYUNG DAICOM LTD. (9097899)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- February 16, 2007
- Registered through
- 2026
- Brand names listed
- Headgear, Instrument, Mirror
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Headgear, Extraoral, Orthodontic | DZB | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Ligature Tucking, Orthodontic | ECP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| October 3, 2011 | K111169 | PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF | DZB | Substantially Equivalent | Kwang Myung Daicom, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Ligature Tucking, Orthodontic
- All makers of Headgear, Extraoral, Orthodontic
- All makers of Mirror, Mouth
Updated October 3, 2011. 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.