Manufacturer registered with FDA
Garnet Dentech
Daegu, South Korea. Lists 10 dental device types with FDA across 1 registered establishment.
- Device types listed
- 10
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1South Korea
Devices listed with FDA
What Garnet Dentech currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Face MaskOrthodontic Wire | 2025 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Mouth Mirror | 2025 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | Crimpable hooks | 2025 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | Aligner tray seater | 2025 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Proxi brush | 2025 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | Dental Orthodontic Strip | 2025 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Dental Retractor | 2025 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Metal Bracket | 2025 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | ORTHODONTIC PLIERS | 2025 |
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Maker | ORTHODONTIC CERAMIC BRACKET | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Garnet Dentech lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Star Dentech Korea., Corp (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 27 May 2009 | K090567 | ORTHODONTIC CERAMIC BRACKET | Star Dentech Korea., Corp | NJM Orthodontic Ceramic Bracket |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GARNET DENTECH CorpFDA reg. 3029683441 | Daegu, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092396). 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.