Manufacturer registered with FDA
Dentca, Inc.
Irvine, CA, United States. Lists 5 dental device types with FDA across 1 registered establishment, and holds 6 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 8
- 510(k) clearances
- 62015–2026
- Markets registered in
- 735 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name Dentca, 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 | Dentca, Inc. | 6 clearances | 2015–2026 | Below |
| Canada | Health Canada | Registration holder | DENTCA, INC. | 15 | 2019–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | DENTCA, Inc.Dentca, Inc. · Dentca, Inc | 7 | 2017–2019 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | DENTCA, Inc. | 6 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Dentca Inc | 3 | 2022–2022 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | DENTCA, Inc. | 3 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DENTCA, INC. | 1 | 2022–2022 | 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 Dentca, 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 |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | DENTCA Base Hi-ImpactDENTCA Base PremiumDENTCA Denture Base II/DENTCA Try-In | 2017 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | DENTCA Crown and Bridge | 2020 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | DENTCA Tray | 2014 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | DENTCA DesignPala Design Studio | 2019 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | DENTCA Denture Teeth | 2018 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Dentca, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 1 Jul 2026 | K261474 | DENTCA Tru Flexible | EBI Rebasing Repairing Relining Denture Resin |
| 17 Nov 2022 | K220042 | Dentca Base Premium, Dentca Base Hi-Impact | EBI Rebasing Repairing Relining Denture Resin |
| 5 Feb 2020 | K192806 | DENTCA Crown and Bridge | EBG Resin Temporary Crown and Bridge |
| 22 Nov 2017 | K172398 | DENTCA DENTURE Teeth | PZY Resin Denture Tooth Preformed Additively Manufactured |
| 3 Mar 2017 | K162044 | Dentca Denture Base II | EBI Rebasing Repairing Relining Denture Resin |
| 21 Jul 2015 | K143033 | DENTCA DENTURE BASE | EBI Rebasing Repairing Relining Denture Resin |
Some of these clearances are listed with FDA today by another company: Kulzer, LLC (2).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTCA, INC.FDA reg. 3009312537 | Irvine, CA, United States | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10039139). 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.