Data / Medical devices / United States / Dental Plus Usa, LLC
Dental Plus Usa, LLC: FDA-registered device maker in South Jordan, UT, United States, 4 510(k) clearances
Dental Plus Usa, LLC is registered with the FDA (registration 3027494823) in South Jordan, UT, United States. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 12, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3027494823
- Address
- 1188 West 10400 South, South Jordan, UT, United States, 84095
- Owner or operator
- Dental Plus USA, LLC (10088429)
- Roles
- Repackager or relabeler, Reprocessor
- First device listed
- January 28, 2025
- Registered through
- 2026
- Brand names listed
- G-CAM, Multi-Unit Analog, Screw, Abutment, PMMA, Silicone gingival mask
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Repackager or relabeler, Reprocessor | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Repackager or relabeler, Reprocessor | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Repackager or relabeler, Reprocessor | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Repackager or relabeler, Reprocessor | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Repackager or relabeler, Reprocessor | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Repackager or relabeler, Reprocessor | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Repackager or relabeler, Reprocessor | 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 |
|---|---|---|---|---|---|---|
| May 12, 2023 | K223706 | PMMA BLOCK | EBG | Substantially Equivalent | Huliang(Shanghai) Bio-Tech Co., Ltd. | accessdata.fda.gov |
| August 16, 2022 | K220329 | G-CAM | EBF | Substantially Equivalent | Graphenano Dental S.L. | accessdata.fda.gov |
| August 8, 2022 | K221668 | Dental Impression Material | ELW | Substantially Equivalent | Chemoment Materials Co.,Ltd | accessdata.fda.gov |
| April 1, 2020 | K200188 | DSI Dental Implant System | DZE | Substantially Equivalent | Dsi Dental Solutions, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Impression
- All makers of Material, Tooth Shade, Resin
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
Updated May 12, 2023. 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.