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
97–120 of 1543
Cleared Aug 08, 2023
LW Implant System
K223924
Ossvis Co., Ltd.
Dental · 221d
Cleared Jul 31, 2023
ZENEX Implant System_Narrow
K230630
Izenimplant Co., Ltd.
Dental · 146d
Cleared Jul 18, 2023
Bone Chamber Implant
K223339
Megagen Implant Co., Ltd.
Dental · 259d
Cleared Jul 07, 2023
IH Implant System
K222707
Sewonmedix, Inc.
Dental · 303d
Cleared Jul 01, 2023
NB Implant System
K230725
Arum Dentistry Co., Ltd.
Dental · 107d
Cleared Jun 26, 2023
Z7 Zirconia Implant System
K221488
Z7, LLC
Dental · 399d
Cleared Jun 24, 2023
BR SLA Type Implant System
K222142
Biotem Co., Ltd.
Dental · 339d
Cleared Jun 23, 2023
Neodent Implant System - Helix Short Implant System
K223638
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 200d
Cleared Jun 22, 2023
Straumann SLActive labeling changes
K223083
Institut Straumann AG
Dental · 265d
Cleared Jun 14, 2023
IR SLA Type Implant System
K222144
Biotem Co., Ltd.
Dental · 329d
Cleared Jun 08, 2023
SNUCONE Tissue Level Implant System
K222792
Snucone Co., Ltd.
Dental · 265d
Cleared Jun 04, 2023
Stella
K221752
Shinhung Mst Co., Ltd.
Dental · 353d
Cleared May 25, 2023
Genesis ACTIVE Implant System
K223814
Keystone Dental, Inc.
Dental · 156d
Cleared Apr 13, 2023
Point implant system
K222738
Pointnix Co., Ltd.
Dental · 216d
Cleared Mar 06, 2023
Provata Implant System
K222457
Southern Implants (Pty), Ltd.
Dental · 203d
Cleared Feb 02, 2023
Implant Direct Dental Implant Systems Portfolio - MR Conditional
K222211
Implant Direct Sybron Manufacturing, LLC
Dental · 192d
Cleared Jan 13, 2023
S-Mono
K221317
Shinhung Mst Co., Ltd.
Dental · 252d
Cleared Jan 06, 2023
BLUEDIAMOND IMPLANT, Abutment Screw
K211812
Megagen Implant Co., Ltd.
Dental · 574d
Cleared Dec 20, 2022
Bonafix 2 Plus
K213677
Zentek Medical, LLC
Dental · 393d
Cleared Dec 20, 2022
IBS System
K220517
Innobiosurg Co., Ltd.
Dental · 300d
Cleared Dec 15, 2022
S.I.N. Dental Implant System
K221453
S.I.N. ? Sistema DE Implante Nacional S.A.
Dental · 210d
Cleared Dec 14, 2022
Magicore Narrow System
K220079
Innobiosurg Co., Ltd.
Dental · 338d
Cleared Dec 14, 2022
QRS Dental Implants System
K221910
Qrs Medical , Ltd.
Dental · 167d
Cleared Nov 16, 2022
PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)
K220841
Dentsply Sirona
Dental · 238d