Cleared Traditional

GEN5 and GEN5+ Dental Implant System

K251938 · Paragon Implant Mfg., LLC · Dental
Oct 2025
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K251938 is an FDA 510(k) clearance for the GEN5 and GEN5+ Dental Implant System, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Paragon Implant Mfg., LLC (Calabasas, US). The FDA issued a Cleared decision on October 30, 2025, 128 days after receiving the submission on June 24, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K251938 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

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