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 Megagen Implant Co., Ltd..

1543
Total
1543
Cleared
202d
Avg days
1976
Since
1543 devices
73–96 of 1543
Cleared Apr 26, 2024
NB Mini Implant System
K240091
Arum Dentistry Co., Ltd.
Dental · 105d
Cleared Apr 11, 2024
Ni2 Implant System
K221847
Newton Implant Systems, Inc.
Dental · 657d
Cleared Apr 01, 2024
External Hex Implant System
K232726
Southern Implants (Pty), Ltd.
Dental · 208d
Cleared Mar 28, 2024
IS-III active Short Implant
K232049
Neobiotech Co., Ltd.
Dental · 262d
Cleared Mar 25, 2024
STERI-OSS Implant System
K232268
Zeros Co., Ltd.
Dental · 238d
Cleared Mar 20, 2024
Straumann® BLC and TLC Implants - Line extension
K234049
Institut Straumann AG
Dental · 90d
Cleared Jan 18, 2024
S-Plant Dental Implant System
K221866
Newton Implant Systems, Inc.
Dental · 570d
Cleared Dec 29, 2023
UniFit Dental Implant System
K223714
Adin Dental Implant Systems , Ltd.
Dental · 382d
Cleared Dec 29, 2023
URIS Smart Path Implant System & Prosthetic
K230438
Truabutment, Inc.
Dental · 311d
Cleared Dec 19, 2023
ZENEX Implant System_Short
K233163
Izenimplant Co., Ltd.
Dental · 83d
Cleared Dec 18, 2023
S-Plant Dental Implant System
K231429
Idis Co., Ltd.
Dental · 215d
Cleared Dec 07, 2023
S.I.N. Dental Implant System
K231127
S.I.N. ? Sistema DE Implante Nacional S.A.
Dental · 231d
Cleared Dec 07, 2023
ARi ExCon Implant System
K231967
Megagen Implant Co., Ltd.
Dental · 157d
Cleared Dec 01, 2023
Single Platform SP1 Implant System
K232418
Southern Implants (Pty), Ltd.
Dental · 112d
Cleared Oct 31, 2023
Neodent Implant System - GM Zygomatic Implant System
K232099
JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A.
Dental · 110d
Cleared Oct 25, 2023
UNIdental Symphony Implant System
K221315
Unidental Co., Ltd.
Dental · 537d
Cleared Oct 18, 2023
INNO SLA Submerged Narrow Implant System
K231395
Cowellmedi Co., Ltd.
Dental · 156d
Cleared Oct 16, 2023
Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL
K230104
Anthogyr
Dental · 276d
Cleared Oct 13, 2023
MRI compatibility for existing BioHorizons dental implants and abutments
K223697
BioHorizons Implant Systems, Inc.
Dental · 308d
Cleared Oct 11, 2023
MegaGen Dental Implant Systems Portfolio - MR Conditional
K230618
Megagen Implant Co., Ltd.
Dental · 219d
Cleared Oct 05, 2023
OsteoCentric Dental Implant System
K230242
OsteoCentric Technologies
Dental · 248d
Cleared Sep 23, 2023
Osstem Implant System
K222778
Osstem Implant Co., Ltd.
Dental · 374d
Cleared Sep 14, 2023
Straumann® BLC and TLC Implants
K230108
Institut Straumann AG
Dental · 244d
Cleared Aug 23, 2023
Oneday Mini Implant System
K222946
Oneday Biotech Co., Ltd.
Dental · 330d