Registered with FDA
Dental Plus USA, LLC
South Jordan, UT, United States. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Dental Plus USA, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | G-CAMPMMA | 2025 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Lister | G-CAMPMMA | 2025 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Lister | Multi-Unit Analog, Screw, Abutment | 2025 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | G-CAM | 2025 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | Silicone gingival mask | 2025 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Lister | Multi-Unit Analog, Screw, Abutment | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Dental Plus USA, LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Huliang (shanghai) Bio-Tech Co., Ltd. (1), Graphenano Dental, SL (1), Chemoment Materials Co.,ltd (1), DSI Dental Solutions Ltd (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 12 May 2023 | K223706 | PMMA BLOCK | Huliang (shanghai) Bio-Tech Co., Ltd. | EBG Resin Temporary Crown and Bridge |
| 16 Aug 2022 | K220329 | G-CAM | Graphenano Dental, SL | EBF Resin Tooth Shade Material |
| 8 Aug 2022 | K221668 | Dental Impression Material | Chemoment Materials Co.,ltd | ELW Impression Material |
| 1 Apr 2020 | K200188 | DSI Dental Implant System | DSI Dental Solutions Ltd | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTAL PLUS USA, LLCFDA reg. 3027494823 | South Jordan, UT, United States | Repacker / relabeler, Reprocessor |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10088429). 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.