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
169–192 of 1543
Cleared Jun 17, 2021
MIS Lance+ Conical Connection Dental Implant System
K210886
Dentsply Sirona
Dental · 84d
Cleared Jun 04, 2021
Dentis s-Clean s-Line Mini
K210080
Dentis Co., Ltd.
Dental · 143d
Cleared May 26, 2021
Implacil Implant System
K202832
Implacil DE Bortoli Material Odontologico Ltda
Dental · 243d
Cleared May 14, 2021
BoneTrust Mini Implant System
K200573
Medical Instinct Deutschland GmbH
Dental · 435d
Cleared Apr 22, 2021
IDCAM Dental Implants
K200329
Implants Diffusion International
Dental · 437d
Cleared Apr 19, 2021
Dentis s-Clean s-Line
K210134
Dentis Co., Ltd.
Dental · 90d
Cleared Apr 15, 2021
Locator Overdenture Implant System
K203701
Ivory Super Holdco Inc. / Zest Anchors, LLC
Dental · 118d
Cleared Mar 18, 2021
s-Clean SQ-SL Implant System Mini
K202773
Dentis Co., Ltd.
Dental · 178d
Cleared Mar 15, 2021
Neodent Implant System-Easy Pack
K203382
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 118d
Cleared Feb 17, 2021
s-Clean SQ-SL Implant System Regular
K210132
Dentis Co., Ltd.
Dental · 29d
Cleared Feb 11, 2021
DSP Implant System
K192839
D.S.P Industrial Eireli
Dental · 504d
Cleared Feb 08, 2021
Straumann 4 mm Short Implants
K202942
Straumann USA, LLC
Dental · 131d
Cleared Jan 22, 2021
Simply Iconic Implants
K201553
Implant Direct Sybron Manufacturing, LLC
Dental · 226d
Cleared Jan 13, 2021
BEGO Semados® RS/RSX Implant System
K201700
Bego Implant Systems GmbH & Co. KG
Dental · 205d
Cleared Dec 22, 2020
Neodent Implant System - Zirconia Implant System
K201491
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 201d
Cleared Dec 01, 2020
Z5-TL
K201712
Z-Systems AG
Dental · 161d
Cleared Nov 17, 2020
S.I.N. Dental Implant System
K200992
S.I.N. ? Sistema DE Implante Nacional S.A.
Dental · 216d
Cleared Nov 16, 2020
TiUltra Implants and Xeal Abutments
K202344
Nobel Biocare AB
Dental · 90d
Cleared Nov 10, 2020
JTK Dental Implant System
K183044
Jiangyin Jintech Biotech Co., Ltd.
Dental · 739d
Cleared Oct 20, 2020
MS Lide Implant Systems
K181477
Hangzhou Minsheng Lide Medical Science & Technology Co., Ltd.
Dental · 868d
Cleared Oct 16, 2020
MINICONE Implant
K200906
Medentika GmbH
Dental · 193d
Cleared Oct 14, 2020
Z5-BL
K200386
Z-Systems AG
Dental · 239d
Cleared Oct 07, 2020
URIS OMNI Narrow System & Prosthetic
K200817
Truabutment, Inc.
Dental · 191d
Cleared Sep 29, 2020
Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants
K193401
Altatec GmbH
Dental · 298d