# K261392: TriActive Dental Implant System

- Pathway: 510(k) (Abbreviated)
- Applicant: Paragon Implant Mfg., LLC
- Decided: Sep 17, 2026 after 141 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K960026 (1996). 325 ancestors in all.
No later device cites it as a predicate yet.
0 of 326 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251938: GEN5 and GEN5+ Dental Implant System, Paragon Implant Mfg., LLC (2025) Summary page 6.
- K170588: DESS Dental Smart Solutions, Terrats Medical SL (2017) Summary page 7.

## Indications for use
TriActive implants are two-piece implants for one- or two-stage surgical procedures. These implants are indicated for use in partially or fully edentulous upper and lower jaws in support of single- or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. TriActive Implants can be indicated for immediate function when initial implant stability has been achieved and with appropriate occlusal loading. Short (<8.5mmL) TriActive Implants: Indicated for single tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization. Narrow (<3.7mmD) TriActive Implants are indicated for single tooth replacement of mandibular central and lateral incisors, and maxillary lateral incisors, or splinted to other dental implants for multi-unit fixed or removable partial prostheses, or for denture stabilization. The TriActive Abutment System is intended for use with TriActive dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients, using traditional crown & bridge techniques. All digitally designed custom abutments for use with DESS Bases or Blanks are to be sent to a Terrats Medical SL validated milling center for manufacture. The TriActive Implant bodies are indicated for compatibility with the following abutments systems: * Ti-base Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees o Active Hex * Ti-blank Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees o Active Hex » CoCr Base Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees o Active Hex * CoCr Blank Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees o Active Hex * Angled Multi-Unit Abutments manufactured by Terrats Medical SL., platform NP and RP, Angled, max 30 degrees o Active Hex » Stock Straight Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees o Active Hex * Locator Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees o Active Hex

Source page: https://510kreport.com/device/K261392
Methodology: https://510kreport.com/methodology