Cleared Abbreviated

K261392 - TriActive Dental Implant System

K261392 is an FDA 510(k) clearance for TriActive Dental Implant System, manufactured by Paragon Implant Mfg., LLC. The device is a Class 2 Dental device with product code DZE cleared through the Abbreviated 510(k) pathway after a 141-day FDA review.

K261392 · Paragon Implant Mfg., LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
141d
Days
Class 2
Risk

K261392 is an FDA 510(k) clearance for the TriActive Dental Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Paragon Implant Mfg., LLC (Calabasas, US). The FDA issued a Cleared decision on September 17, 2026 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Paragon Implant Mfg., LLC devices

FDA 510(k) Submission Details - K261392

510(k) Number K261392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2026
Decision Date September 17, 2026
Days to Decision 141 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 128d · This submission: 141d
Pathway characteristics
Standards-based clearance path.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1372
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K261392.
ZEROS Dental Implant System
K260463 · Zeros Co., Ltd. · Aug 2026
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Dental Implant System
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MegaGen Zygoma Dental Implant System
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INOSS System
K260006 · Inosys, Inc. · Jun 2026
Promimic ZrP Surface Dental Implant
K252731 · Promimic AB · May 2026