Data / Medical devices / United States / Paragon Implant MFG., LLC
Paragon Implant MFG., LLC: FDA-registered device maker in Calabasas, CA, United States, 5 510(k) clearances
Paragon Implant MFG., LLC is registered with the FDA (registration 3005409899) in Calabasas, CA, United States. It lists 5 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.
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
- 3005409899
- Address
- 27030 Malibu Hills Rd, Calabasas, CA, United States, 91301
- Owner or operator
- Paragon Implant Mfg., LLC (10088975)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- September 23, 2024
- Registered through
- 2027
- Brand names listed
- Angle Measuring Guide, Complete Surgical Kit, Crestal Drill, Drill Extender, Drill Stop Kit, Drill Stops, GEN5 Implants and Prosthetics, GEN5 and GEN5+ 3.3mm Implants and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Non-Irrigation Endosseous Dental Implant Drill Bits | QRQ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Complaint file establishment, 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 Accessories, Implant, Dental, Endosseous
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Non-Irrigation Endosseous Dental Implant Drill Bits
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.