Data / Medical devices / United States / Paragon Implant Company, LLC
Paragon Implant Company, LLC: FDA-registered device maker in Las Vegas, NV, United States, 5 510(k) clearances
Paragon Implant Company, LLC is registered with the FDA (registration 3033708818) in Las Vegas, NV, United States. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 17, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3033708818
- Address
- 8840 W Russell Rd Ste 200, Las Vegas, NV, United States, 89148
- Owner or operator
- Paragon Implant Company, LLC (10091708)
- Roles
- Manufacturer
- First device listed
- October 25, 2024
- Registered through
- 2027
- Brand names listed
- Complete Surgical Kit, Dental manual instruments, Drill Stop Kit, GEN5 Implants and Prosthetics, GEN5 and GEN5+ Implants, GEN5+ Implants and Prosthetics, NizLoc, NizPlant and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| September 17, 2026 | K261392 | TriActive Dental Implant System | DZE | Substantially Equivalent | Paragon Implant Mfg., LLC | accessdata.fda.gov |
| December 23, 2025 | K252145 | GEN5 and GEN5+ 3.3mmD Dental Implants | DZE | Substantially Equivalent | Paragon Implant Mfg., LLC | accessdata.fda.gov |
| December 23, 2025 | K250476 | NizPlant Dental Implant System | DZE | Substantially Equivalent | Paragon Implant Mfg., LLC | accessdata.fda.gov |
| November 14, 2025 | K251756 | Sterilization Trays | KCT | Substantially Equivalent | Paragon Implant Mfg., LLC | accessdata.fda.gov |
| October 30, 2025 | K251938 | GEN5 and GEN5+ Dental Implant System | DZE | Substantially Equivalent | Paragon Implant Mfg., LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Abutment, Implant, Dental, Endosseous
Updated September 17, 2026. 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.