Data / Medical devices / United States / Otc Dental
Otc Dental: FDA-registered device maker in N Las Vegas, NV, United States, 1 510(k) clearance
Otc Dental is registered with the FDA (registration 3013425656) in N Las Vegas, NV, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 16, 1998. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013425656
- Address
- 3825 W Cheyenne Ave Ste 606, N Las Vegas, NV, United States, 89032
- Owner or operator
- OTC Dental (10053689)
- Roles
- Repackager or relabeler
- First device listed
- January 15, 2026
- Registered through
- 2026
- Brand names listed
- DenSureFit, DenSureFitPro
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 16, 1998 | K974865 | CSR | EBI | Substantially Equivalent | Parkell, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 16, 1998. 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.