Manufacturer registered with FDA
Dentkist, Inc.
Gunpo-si, South Korea. Lists 2 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 17
- 510(k) clearances
- 22016–2020
- Markets registered in
- 751 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name Dentkist, Inc. 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 | Dentkist, Inc. | 2 clearances | 2016–2020 | Below |
| Saudi Arabia | SFDA | Manufacturer | Dentkist. Inc | 17 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DentKist Inc.DENTKIST, INC. | 14 | 2011–2020 | Pure Global AI |
| Egypt | EDA | Manufacturer | DentKist, Inc,DentKist, Inc., | 9 | 2026–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DENTKIST, INC. | 8 | 2018–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | DentKist Inc | 2 | 2024–2024 | Pure Global AI |
| China | NMPA | Registration holder | 韩国登克斯特有限公司Dentkist Inc.((주)덴키스트) | 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 Dentkist, Inc. 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 Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | CharmFil FlowCharmFil PlusCharmFil Plus CapsFlow Resin ALOOZ | 2020 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | CharmFlex®BiteCharmFlex®Bite ClearCharmFlex®Bite FastCharmFlex®DentureCharmFlex®Heavy cartridge typeCharmFlex®Heavy tube typeCharmFlex®Light LVCharmFlex®Light PremiumCharmFlex®Light XLVCharmFlex®Putty 3 moreCharmFlex®Putty GreenCharmFlex®Putty SoftCharmFlex®Regular | 2016 |
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 |
|---|---|---|
| DENTKIST, INC.FDA reg. 3013012934 | Gunpo-si Gyeonggi, South Korea | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10052020). 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.