Data / Medical devices / South Korea / Handae Chemical Co., Ltd
Handae Chemical Co., Ltd: FDA-registered device maker in Jincheon-gun Chungbuk, South Korea, 2 510(k) clearances
Handae Chemical Co., Ltd is registered with the FDA (registration 3004605596) in Jincheon-gun Chungbuk, South Korea. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 15, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004605596
- Address
- 56-28, Songdu 4-gil, Jincheon-eup, Jincheon-gun Chungbuk, South Korea, 27845
- Owner or operator
- Handae Chemical Co., Ltd (10035933)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- April 5, 2011
- Registered through
- 2026
- Brand names listed
- Delikit Bite Registration Premium, Delikit Heavy Body Premium, Delikit Light Body Premium, PERFECT BITE, PERFECT-F VPS FIT CHECKER, PERFECT-F VPS HEAVY BODY, PERFECT-F VPS LIGHT BODY, PERFECT-F VPS PUTTY and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Material, Impression | ELW | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 15, 2014 | K140966 | VONFLEX S BITE | ELW | Substantially Equivalent | Vericom Co., Ltd. | accessdata.fda.gov |
| December 3, 2004 | K042860 | CORRECT DENTAL IMPRESSION MATERIAL | ELW | Substantially Equivalent | Handae Chemical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 15, 2014. 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.