Manufacturer registered with FDA
CK Dental Ind Co Ltd
BUCHEON-SI, GYEONGGI-DO, South Korea. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 820 registrations outside the US
- Establishments
- 1South Korea
Registered in 8 markets
Where regulators' registries name CK Dental Ind 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 | CK Dental Ind Co Ltd | 1 device types | — | Below |
| Colombia | INVIMA | Manufacturer | C-K DENTAL IND.CO LTDC-K DENTAL IND. CO., LTD. | 7 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | C-K DENTAL IND.CO.,LTD.C-K DENTAL IND.CO.LTD · C-K Dental Ind. Co., Ltd. · +1 | 4 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | C-K DENTAL IND. CO., LTD.C-K Dental IND. CO., LTD | 3 | 2006–2018 | Pure Global AI |
| Australia | TGA | Manufacturer | CK Dental Ind Co Ltd | 2 | 2017–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | CK DENTAL IND. CO., LTD | 2 | 2011–2018 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | CK DENTAL IND. CO. LTD. | 1 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | CK-Dental Ind. Co. Ltd | 1 | — | 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 CK Dental Ind 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 |
|---|---|---|---|---|
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | — | 2005 |
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 |
|---|---|---|
| C-K DENTAL IND. CO., LTD.FDA reg. 3005416271 | BUCHEON-SI, GYEONGGI-DO, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9078828). 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.