# TriActive Dental Implant System (K261392): 510(k) cleared for Paragon Implant Mfg., LLC

**Predicate Speed & CAPA Advisory Opportunity Score:** 35/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261392 |
| Device | TriActive Dental Implant System |
| Applicant | Paragon Implant Mfg., LLC |
| Specialty / panel | Dental |
| Product code | DZE |
| Device class | 2 |
| Clearance type | Abbreviated |
| Decision | Substantially Equivalent |
| Received | 2026-04-29 |
| Decision date | 2026-09-17 |
| Review time (days) | 141 |
| Third-party review | No |
| Applicant location | Calabasas, CA, US |

## Why this score
- Fast 141-day review: this device is a strong predicate for similar products.
- Abbreviated 510(k): a modification of an existing device.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261392). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.