Data / Medical devices / South Korea / Dentkist, Inc.
Dentkist, Inc.: FDA-registered device maker in Gunpo-si Gyeonggi, South Korea, 1 510(k) clearance
Dentkist, Inc. is registered with the FDA (registration 3013012934) in Gunpo-si Gyeonggi, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 8, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013012934
- Address
- (Dangjeong-dong) 3, Nongshim-ro, Gunpo-si Gyeonggi, South Korea, 15842
- Owner or operator
- Dentkist, Inc. (10052020)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 1, 2016
- Registered through
- 2026
- Brand names listed
- CharmFil Flow, CharmFil Plus, CharmFil Plus Caps, CharmFlex®Bite, CharmFlex®Bite Clear, CharmFlex®Bite Fast, CharmFlex®Denture, CharmFlex®Heavy cartridge type and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Material, Impression | ELW | 2 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| March 8, 2016 | K152766 | CharmFlex | ELW | Substantially Equivalent | Dentkist, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 8, 2016. 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.