Cleared Traditional

GEN5? and GEN5+? 3.3mmD Dental Implants

K252145 · Paragon Implant Mfg., LLC · Dental

Dec 2025

Decision

167d

Days

Class 2

Risk

About This 510(k) Submission

K252145 is an FDA 510(k) clearance for the GEN5? and GEN5+? 3.3mmD Dental Implants, 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 December 23, 2025, 167 days after receiving the submission on July 9, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K252145 FDA.gov
FDA Decision	Cleared 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