510(k) clearance

TriActive Dental Implant System

FDA 510(k) source

510(k) number

K261392

Applicant

Paragon Implant Mfg., LLC

Decision date

Sep 17, 2026

Date received

Apr 29, 2026

Decision

Substantially Equivalent

Clearance type

Abbreviated

Product code

DZE

Device type

Implant, Endosseous, Root-Form

Device class

Class II

Regulation

21 CFR 872.3640

Advisory committee

Dental

Statement or summary

Summary

Third party

N

Location

Calabasas, CA, US