Manufacturer registered with FDA
Paragon Implant Company, LLC
Las Vegas, NV, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 13
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Paragon Implant Company, 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 |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | GEN5 and GEN5+ ImplantsGEN5 Implants and ProstheticsGEN5+ Implants and ProstheticsNizLocNizPlantTriActive Dental Implant System | 2025 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | GEN5 Implants and ProstheticsGEN5+ Implants and ProstheticsNizLocNizPlantTriActive Dental Implant System | 2025 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Dental manual instrumentsSurgical Drills | 2024 |
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
Paragon Implant Company, 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: Paragon Implant Mfg., LLC (4).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 17 Sep 2026 | K261392 | TriActive Dental Implant System | Paragon Implant Mfg., LLC | DZE Root-Form Endosseous Implant |
| 23 Dec 2025 | K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC | DZE Root-Form Endosseous Implant |
| 23 Dec 2025 | K252145 | GEN5 and GEN5+ 3.3mmD Dental Implants | Paragon Implant Mfg., LLC | DZE Root-Form Endosseous Implant |
| 30 Oct 2025 | K251938 | GEN5 and GEN5+ Dental Implant System | Paragon Implant Mfg., LLC | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PARAGON IMPLANT COMPANY, LLCFDA reg. 3033708818 | Las Vegas, NV, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10091708). 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.