Cleared Traditional

Neodent Implant System - Zirconia Implant System

K250271 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · Dental
Aug 2025
Decision
200d
Days
Class 2
Risk

About This 510(k) Submission

K250271 is an FDA 510(k) clearance for the Neodent Implant System - Zirconia Implant System, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. (Curitiba, BR). The FDA issued a Cleared decision on August 18, 2025, 200 days after receiving the submission on January 30, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K250271 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2025
Decision Date August 18, 2025
Days to Decision 200 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

Similar Devices — DZE Implant, Endosseous, Root-form

All 1539
Straumann? BLC Implants - Indication Widening
K252168 · Institut Straumann AG · Mar 2026
Dentis SQ-SL AXEL Fixture
K253493 · Dentis Co., Ltd. · Mar 2026
Nobel Biocare S Series Implants
K252197 · Nobel Biocare AB · Feb 2026
BIORES Dental Implant System
K252286 · Chengdu Besmile Medical Technology Co., Ltd. · Feb 2026
ZENEX Implant System_R-System
K252585 · Izenimplant Co., Ltd. · Jan 2026
GEN5? and GEN5+? 3.3mmD Dental Implants
K252145 · Paragon Implant Mfg., LLC · Dec 2025