Data / Medical devices / South Korea / Sherpa Korea
Sherpa Korea: FDA-registered device maker in Saha-gu Busan, South Korea, 2 510(k) clearances
Sherpa Korea is registered with the FDA (registration 3008922120) in Saha-gu Busan, South Korea. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 11, 2011. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008922120
- Address
- 438-1, Hasinbeonyeong-ro, Saha-gu Busan, South Korea, 49301
- Owner or operator
- Sherpa (10035326)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- February 21, 2011
- Registered through
- 2027
- Brand names listed
- DXM Mixing Tips, Deli Bite Clear, Deli-Boarder, Deli-Temp, Delikit Bite Registration, Delikit Denture Soft Reliner, Delikit Denture VPS, Delikit Extra Light Body Fast Set and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Gutta-Percha | EKM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Margin Finishing, Operative | EJZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Manufacturer | accessdata.fda.gov |
| Reliner, Denture, Over The Counter | EBP | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 11, 2011 | K103346 | DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY | ELW | Substantially Equivalent | Sherpa Korea | accessdata.fda.gov |
| February 14, 2001 | K010012 | LC PROVIFILL | EBG | Substantially Equivalent | S & C Polymer GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Restorative And Impression Material
- All makers of Reliner, Denture, Over The Counter
- All makers of Gutta-Percha
- All makers of Knife, Margin Finishing, Operative
- All makers of Tray, Impression, Preformed
- All makers of Material, Impression
Updated February 11, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.