Cleared Traditional

K251938 - GEN5 and GEN5+ Dental Implant System

K251938 is an FDA 510(k) clearance for GEN5 and GEN5+ Dental Implant System, manufactured by Paragon Implant Mfg., LLC. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K251938 · Paragon Implant Mfg., LLC · Dental device
Download Printable Device Report (PDF)
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Oct 2025
Decision
128d
Days
Class 2
Risk

K251938 is an FDA 510(k) clearance for the GEN5 and GEN5+ 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 October 30, 2025 after a review of 128 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 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

FDA 510(k) Submission Details - K251938

510(k) Number K251938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2025
Decision Date October 30, 2025
Days to Decision 128 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
1d slower than avg
Panel avg: 127d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 758
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K251938.
DIMPLO Implant System
K251605 · DIMPLO, Ltd. · Dec 2025
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HexaPLUS S OneDrill Implant System
K243078 · Osseofuse International, Inc. · Oct 2025
Paltop Dental Implant System
K243983 · Paltop Advanced Dental Solutions, Ltd. · Sep 2025
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K251262 · S.I.N. Implant System Ltda · Sep 2025