Manufacturer registered with FDA
DENKEN-HIGHDENTAL Co., Ltd.
Kyoto, Japan. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 5
- 510(k) clearances
- 12022–2022
- Markets registered in
- 318 registrations outside the US
- Establishments
- 1Japan
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name DENKEN-HIGHDENTAL Co., Ltd. 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 | DENKEN-HIGHDENTAL Co., Ltd. | 1 clearances | 2022–2022 | Below |
| South Korea | MFDS | Manufacturer | DENKEN-HIGHDENTAL CO., LTDDENKEN-HIGH DENTAL CO., LTD. · DENKEN-HIGHDENTAL CO., LTD. · +2 | 16 | 2002–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DENKEN-HIGHDENTAL CO., LTD. | 2 | 2014–2018 | 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 DENKEN-HIGHDENTAL Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | AcryFlex, FlexFit, ClearFit, TurboFix, QuickBaseRezen NF, Acry Tone, Bio Tone, Acry Jet, Bio Plast, ISO Fast, ISO Resin-H, ISO Resin-Q, Resin Primer, Super PrimerSuper Primer | 2013 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Kolben Wax, Sprue Wax | 2013 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | KDF Zirconia Disc | 2023 |
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
DENKEN-HIGHDENTAL Co., Ltd. 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: Dentsoll, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 26 Jul 2013 | K130680 | ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS | Dentsoll, Inc. | EBI Rebasing Repairing Relining Denture Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENKEN-HIGHDENTAL Co., Ltd.FDA reg. 3010564008 | Kyoto, Japan | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10045737). 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.