Manufacturer registered with FDA
JISCOP Co., Ltd.
Gunpo-si, South Korea. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 57 registrations outside the US
- Establishments
- 1South Korea
Registered in 5 markets
Where regulators' registries name JISCOP 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 | JISCOP Co., Ltd. | 7 device types | — | Below |
| Taiwan | TFDA | Manufacturer | JISCOP CO. LTD | 3 | 2012–2016 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | JISCOP CO., LTD | 2 | 2009–2009 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | JISCOP Co., Ltd. | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | JISCOP Co., Ltd. | 1 | 2022–2022 | 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 JISCOP 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 |
|---|---|---|---|---|
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Wire | 2020 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Tube | 2020 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Elastic Band | 2020 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | Orthodontic Wire Clamp | 2020 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Spring | 2020 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Intraoral Dental Wax | 2020 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Orthodontic Metal Bracket | 2020 |
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 |
|---|---|---|
| JISCOP CO., LTD.FDA reg. 3017486669 | Gunpo-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10077059). 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.