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