Data / Medical devices / Japan / DENKEN-HIGHDENTAL Co., Ltd.
DENKEN-HIGHDENTAL Co., Ltd.: FDA-registered device maker in Kyoto, Japan, 2 510(k) clearances
DENKEN-HIGHDENTAL Co., Ltd. is registered with the FDA (registration 3010564008) in Kyoto, Japan. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 14, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010564008
- Address
- 24-3 Kisshoin Ishiharakyomichi-Cho Minami-ku, Kyoto, Japan, 601-8356
- Owner or operator
- DENKEN-HIGHDENTAL Co., Ltd. (10045737)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 23, 2013
- Registered through
- 2026
- Brand names listed
- AcryFlex, FlexFit, ClearFit, TurboFix, QuickBase, KDF Zirconia Disc, Kolben Wax, Sprue Wax, Rezen NF, Acry Tone, Bio Tone, Acry Jet, Bio Plast, ISO Fast, ISO Resin-H, ISO Resin-Q, Resin Primer, Super Primer, Super Primer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powder, Porcelain | EIH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| July 14, 2022 | K221429 | KDF Zirconia Disc | EIH | Substantially Equivalent | Denken-Highdental Co., Ltd. | accessdata.fda.gov |
| July 26, 2013 | K130680 | ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS | EBI | Substantially Equivalent | Dentsoll, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Wax, Dental, Intraoral
- All makers of Powder, Porcelain
Updated July 14, 2022. 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.