Manufacturer registered with FDA
Paragon Implant Mfg., LLC
Calabasas, CA, United States. Lists 4 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 25
- 510(k) clearances
- 42025–2026
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Paragon Implant Mfg., 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+ 3.3mm 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 | Angle Measuring GuideDrill ExtenderDrill StopsHex Latch DriverHex ToolParallelling Guide PinRemoval ToolTorque WrenchTorque Wrench Insert | 2024 |
| Non-Irrigation Endosseous Dental Implant Drill BitsQRQ · Class 1 | Implant instruments & surgical kits | Maker | Crestal DrillHex DrillLinderman DrillStarter DrillStep Drill | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Paragon Implant Mfg., LLC as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 17 Sep 2026 | K261392 | TriActive Dental Implant System | DZE Root-Form Endosseous Implant |
| 23 Dec 2025 | K252145 | GEN5 and GEN5+ 3.3mmD Dental Implants | DZE Root-Form Endosseous Implant |
| 23 Dec 2025 | K250476 | NizPlant Dental Implant System | DZE Root-Form Endosseous Implant |
| 30 Oct 2025 | K251938 | GEN5 and GEN5+ Dental Implant System | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Paragon Implant Company, LLC (4).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PARAGON IMPLANT MFG., LLCFDA reg. 3005409899 | Calabasas, CA, United States | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10088975). 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.