Cleared Traditional

GEN5™ and GEN5+™ 3.3mmD Dental Implants (K252145) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252145 · Paragon Implant Mfg., LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
167d
Days
Class 2
Risk

K252145 is an FDA 510(k) clearance for the GEN5™ and GEN5+™ 3.3mmD Dental Implants. 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 December 23, 2025 after a review of 167 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Paragon Implant Mfg., LLC devices

Submission Details

510(k) Number K252145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2025
Decision Date December 23, 2025
Days to Decision 167 days
Submission Type Traditional
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
40d slower than avg
Panel avg: 127d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 304
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K252145.
BIORES Dental Implant System
K252286 · Chengdu Besmile Medical Technology Co., Ltd. · Feb 2026
ZENEX Implant System_R-System
K252585 · Izenimplant Co., Ltd. · Jan 2026
NizPlant Dental Implant System
K250476 · Paragon Implant Mfg., LLC · Dec 2025
DIMPLO Implant System
K251605 · DIMPLO, Ltd. · Dec 2025
Pterygoid Indication for GM Helix Implants
K252090 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · Dec 2025
S.I.N. Tapered Pro Conical Zygoma Implant System
K251129 · S.I.N. Implant System Ltda · Nov 2025