Manufacturer registered with FDA
Sherpa
Gangseo-gu, South Korea. Lists 7 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 7
- Brands and models
- 31
- 510(k) clearances
- 12011–2011
- Markets registered in
- 59 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Sherpa 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 | Sherpa | 1 clearances | 2011–2011 | Below |
| Australia | TGA | Manufacturer | Sherpa Korea | 4 | 2010–2018 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SHERPA KOREA | 3 | 2012–2014 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SHERPA KOREA | 1 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Sherpa BV | 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 Sherpa currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | Deli-Temp | 2012 |
| Over the Counter Denture RelinerEBP · Class 2 | — | Maker | E&E Extended Working Time Denture Soft Reline Combo KitE&E Extended Working Time Denture Soft Reline KitE&E Fast Set Pro Denture Soft Reline Kit for Upper & Lower DenturesE&E Fast Set Pro Denture Soft Reline Kit for Upper and Lower DenturesE&E Multi-Use Soft Silicone Denture Reline KitE&E Soft Reline Refill 50ml Cartridge | 2023 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | Excel Tray | 2011 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | DXM Mixing Tips | 2025 |
| Operative Margin Finishing KnifeEJZ · Class 1 | Dental hand instruments | Lister | GP Cutter | 2011 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Lister | Gutta Percha | 2011 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | Deli Bite ClearDeli-BoarderDelikit Bite RegistrationDelikit Denture Soft RelinerDelikit Denture VPSDelikit Extra Light Body Fast SetDelikit Extra Light Body Regular SetDelikit Heavy Body Fast SetDelikit Heavy Body Regular SetDelikit Implant Heavy Body 10 moreDelikit Implant Light BodyDelikit Implant Medium BodyDelikit Light Body Fast SetDelikit Light Body Regular SetDelikit Medium BodyDelikit Putty Eco Fast SetDelikit Putty Eco Regular SetE&E Heavy Body Fast Set SiliconeE&E Light Body Fast Set VPS MaterialMoldify Fast Set Silicone Putty | 2011 |
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
Sherpa 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: S & C Polymer GmbH (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 14 Feb 2001 | K010012 | LC PROVIFILL | S & C Polymer GmbH | EBG Resin Temporary Crown and Bridge |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SHERPA KOREAFDA reg. 3008922120 | Saha-gu Busan, South Korea | Manufacturer, Repacker / relabeler |
Other names on FDA records
Sherpa Korea
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10035326). 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.