Manufacturer registered with FDA
DUNAMIS DENTAL Co., Ltd.
Gwangmyeong-si, South Korea. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 20
- 510(k) clearances
- 0as applicant
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1South Korea
Registered in 2 markets
Where regulators' registries name DUNAMIS DENTAL 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 | DUNAMIS DENTAL Co., Ltd. | 2 device types | — | Below |
| Taiwan | TFDA | Manufacturer | DUNAMIS DENTAL CO., LTDDUNAMIS DENTAL CO., LTD. | 2 | 2009–2012 | 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 DUNAMIS DENTAL 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 |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Karam-AMKaram-ANGKaram-DelixKaram-LabKaram-STRKT15-45ECN S B2KT15-45ECN S M4KT15-45SKKT15-45SLKKT15-45SLN 9 moreKT15-45SNKT15-45SQDKT15-ECN S B2KT15-ECN S M4KT15-SKKT15-SLKKT15-SLNKT15-SNKT15-SQD | 2022 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | SAM | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DUNAMIS DENTAL CO., LTD.FDA reg. 3022396768 | Gwangmyeong-si Gyeonggi, South Korea | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10084538). 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.