DZE · Class II · 21 CFR 872.3640

FDA Product Code DZE: Implant, Endosseous, Root-form

Root-form dental implants are the standard of care for replacing missing teeth. FDA product code DZE covers endosseous root-form implants — titanium or zirconia fixtures that are surgically placed into the jawbone to support prosthetic restorations.

These implants osseointegrate with the surrounding bone to provide a stable, long-term foundation for crowns, bridges, and full-arch rehabilitations. They are used by oral surgeons, periodontists, and implantologists.

DZE devices are Class II medical devices, regulated under 21 CFR 872.3640 and reviewed by the FDA Dental panel.

Leading manufacturers include Institut Straumann AG, Jjgc Industria E Comercio DE Materiais Dentarios S.A. and Southern Implants (Pty), Ltd..

1543
Total
1543
Cleared
202d
Avg days
1976
Since
1543 devices
193–216 of 1543
Cleared Sep 25, 2020
Honorst Implant System
K202039
Medimecca Co., Ltd.
Dental · 64d
Cleared Sep 23, 2020
IBS Implant System
K202479
Innobiosurg Co., Ltd.
Dental · 26d
Cleared Sep 04, 2020
Neodent Implant System - GM Helix Implants 7.0
K201225
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 121d
Cleared Sep 03, 2020
MIS Dental Implant System
K200102
Dentsply Sirona
Dental · 230d
Cleared Aug 27, 2020
Nucleoss T6 Dental Implant System
K192062
Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST
Dental · 392d
Cleared Aug 27, 2020
Magicore System
K201981
Innobiosurg Co., Ltd.
Dental · 42d
Cleared Aug 20, 2020
Straumann TLX Implant System
K200586
Institut Straumann AG
Dental · 167d
Cleared Aug 18, 2020
Keystone Dental XL Dental Implant System
K201334
Keystone Dental, Inc.
Dental · 90d
Cleared Jul 31, 2020
I Do
K192294
I DO Biotech Co., Ltd.
Dental · 343d
Cleared Jun 26, 2020
JDentalCare Implant System JDIcon
K182081
Jdentalcare Srl
Dental · 694d
Cleared Jun 26, 2020
MSDI Dental Implants System
K191443
Medical Systems and Devices International , Ltd.
Dental · 393d
Cleared Jun 25, 2020
Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants
K192221
Implant Direct Sybron Manufacturing, LLC
Dental · 315d
Cleared Jun 19, 2020
Fit & Brilliant Dental Implant System
K190637
F&B Technology Co., Ltd.
Dental · 465d
Cleared Jun 18, 2020
BV Dental Implant System
K192274
Bio Concept Co., Ltd.
Dental · 301d
Cleared Jun 18, 2020
NUVO IF Implant System
K193234
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 206d
Cleared May 14, 2020
S.I.N. Dental Implant System
K193096
S.I.N. ? Sistema DE Implante Nacional S.A.
Dental · 189d
Cleared May 07, 2020
ZAGA Zygomatic System
K192651
Southern Implants (Pty), Ltd.
Dental · 226d
Cleared Apr 28, 2020
Magicore II System
K192197
Innobiosurg Co., Ltd.
Dental · 259d
Cleared Apr 28, 2020
Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants
K193592
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 127d
Cleared Apr 28, 2020
Implantswiss Dental Implant System and Implantswiss Dental Abutment System
K200867
Novodent SA
Dental · 27d
Cleared Apr 13, 2020
s-Clean SQ-SL Implant System Mini
K200099
Dentis Co., Ltd.
Dental · 88d
Cleared Apr 03, 2020
Faico Dental Implant System
K192015
Faico Medical, LLC
Dental · 249d
Cleared Apr 01, 2020
DSI Dental Implant System
K200188
Dsi Dental Solutions, Ltd.
Dental · 68d
Cleared Feb 27, 2020
ST Internal Implant System
K190919
T-Plus Implant Tech. Co., Ltd.
Dental · 324d