Data / Medical devices / United States / Dentca, Inc.
Dentca, Inc.: FDA-registered device maker in Irvine, CA, United States, 4 510(k) clearances
Dentca, Inc. is registered with the FDA (registration 3009312537) in Irvine, CA, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 17, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009312537
- Address
- 17742 Cowan, Irvine, CA, United States, 92614
- Owner or operator
- Dentca, Inc. (10039139)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 12, 2014
- Registered through
- 2026
- Brand names listed
- DENTCA Base Hi-Impact, DENTCA Base Premium, DENTCA Crown and Bridge, DENTCA Denture Base II/DENTCA Try-In, DENTCA Denture Teeth, DENTCA Design, DENTCA Tray, Pala Design Studio
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| November 17, 2022 | K220042 | Dentca Base Premium, Dentca Base Hi-Impact | EBI | Substantially Equivalent | Dentca, Inc. | accessdata.fda.gov |
| February 5, 2020 | K192806 | DENTCA Crown and Bridge | EBG | Substantially Equivalent | Dentca, Inc. | accessdata.fda.gov |
| November 22, 2017 | K172398 | DENTCA DENTURE Teeth | PZY | Substantially Equivalent | Dentca, Inc. | accessdata.fda.gov |
| March 3, 2017 | K162044 | Dentca Denture Base II | EBI | Substantially Equivalent | Dentca, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- All makers of Additively Manufactured, Preformed, Resin Denture Tooth
- All makers of Tray, Impression, Preformed
- All makers of Crown And Bridge, Temporary, Resin
Updated November 17, 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.