Data / Medical devices / South Korea / GARNET DENTECH Corp
GARNET DENTECH Corp: FDA-registered device maker in Daegu, South Korea, 1 510(k) clearance
GARNET DENTECH Corp is registered with the FDA (registration 3029683441) in Daegu, South Korea. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 27, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029683441
- Address
- D-Center 1976, #414, Waryong-ro 307, Seo-gu, Daegu, South Korea, 41756
- Owner or operator
- Garnet Dentech (10092396)
- Roles
- Manufacturer
- First device listed
- January 1, 2025
- Registered through
- 2026
- Brand names listed
- Aligner tray seater, Crimpable hooks, Dental Orthodontic Strip, Dental Retractor, Face Mask, Metal Bracket, Mouth Mirror, ORTHODONTIC CERAMIC BRACKET and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Retractor, Dental | EIF | 1 | Manufacturer | accessdata.fda.gov |
| Bracket, Ceramic, Orthodontic | NJM | 2 | Manufacturer | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Manufacturer | accessdata.fda.gov |
| Clamp, Wire, Orthodontic | ECN | 1 | Manufacturer | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Manufacturer | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Manufacturer | accessdata.fda.gov |
| Pusher, Band, Orthodontic | ECS | 1 | Manufacturer | accessdata.fda.gov |
| Strip, Polishing Agent | EHM | 1 | Manufacturer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 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 |
|---|---|---|---|---|---|---|
| May 27, 2009 | K090567 | ORTHODONTIC CERAMIC BRACKET | NJM | Substantially Equivalent | Star Dentech Korea., Corp | accessdata.fda.gov |
Compare with other makers
- All makers of Clamp, Wire, Orthodontic
- All makers of Bracket, Ceramic, Orthodontic
- All makers of Toothbrush, Manual
- All makers of Plier, Orthodontic
- All makers of Pusher, Band, Orthodontic
- All makers of Mirror, Mouth
Updated May 27, 2009. 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.