Cleared Abbreviated

NizPlant Dental Implant System

K250476 · Paragon Implant Mfg., LLC · Dental
Dec 2025
Decision
307d
Days
Class 2
Risk

About This 510(k) Submission

K250476 is an FDA 510(k) clearance for the NizPlant 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 December 23, 2025, 307 days after receiving the submission on February 19, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K250476 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2025
Decision Date December 23, 2025
Days to Decision 307 days
Submission Type Abbreviated
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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