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
121–144 of 1543
Cleared Nov 16, 2022
OmniTaper EV Dental Implants, DS Implants abutments with EV connection
K221094
Dentsply Sirona
Dental · 216d
Cleared Nov 09, 2022
Zaga Zygomatic System
K222497
Southern Implants (Pty), Ltd.
Dental · 83d
Cleared Oct 27, 2022
S.I.N. Dental Implant System
K222231
S.I.N. ? Sistema DE Implante Nacional S.A.
Dental · 94d
Cleared Oct 19, 2022
Proximerge 2 Dental Implant System
K211409
Quadric Biomed, LLC
Dental · 531d
Cleared Oct 13, 2022
IM/ST Fixture System
K212702
Guilin Fiteeth Medical Instrument Co., Ltd.
Dental · 413d
Cleared Sep 19, 2022
NB 1 SA Implant System
K222131
Arum Dentistry Co., Ltd.
Dental · 63d
Cleared Sep 14, 2022
TSX Implants
K220978
Biomet 3i, LLC
Dental · 163d
Cleared Sep 06, 2022
Neodent Implant System - GM Narrow Implant System
K220251
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 218d
Cleared Aug 10, 2022
BLT Dental Implant System
K212364
Bio Concept Co., Ltd.
Dental · 376d
Cleared Jul 21, 2022
BTI Interna Narrow/Plus Dental Implant System UnicCa
K211952
B.T.I. Biotechnology Institute, Sl.
Dental · 393d
Cleared Jul 15, 2022
Tatum Surgical Dental Implant System
K213576
Suncoast Dental, Inc. Dba Tatum Surgical
Dental · 247d
Cleared Jul 15, 2022
Kontact Dental Implant System
K213997
Biotech Dental, Sas
Dental · 206d
Cleared Jul 13, 2022
SNUCONE Bone Level Implant System
K210354
Snucone Co., Ltd.
Dental · 520d
Cleared Jul 08, 2022
Adin Short Implants
K212775
Adin Dental Implants Systems , Ltd.
Dental · 310d
Cleared Jun 30, 2022
Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments
K212785
Blue Sky Bio, LLC
Dental · 302d
Cleared Jun 24, 2022
Noris Medical Dental Implants System - Cortical
K210852
Noris Medical , Ltd.
Dental · 459d
Cleared May 25, 2022
Paltop Conical Implant System
K220200
Paltop Advanced Dental Solutions, Ltd.
Dental · 121d
Cleared Apr 13, 2022
ZENEX Implant System
K211090
Izenimplant Co., Ltd.
Dental · 366d
Cleared Apr 06, 2022
NB 1 SA Implant System
K213506
Arum Dentistry Co., Ltd.
Dental · 156d
Cleared Apr 04, 2022
TRATE Dental Implant System
K220022
Trate AG
Dental · 89d
Cleared Mar 28, 2022
T3 Pro Implants
K213672
Biomet 3i, LLC
Dental · 126d
Cleared Mar 17, 2022
SICtapered & SICvantage tapered
K210489
Sic Invent AG
Dental · 391d
Cleared Mar 01, 2022
LOTA SLA Dental Implant System and LOTA HA Dental Implant System
K202046
Kj Meditech Co., Ltd.
Dental · 586d
Cleared Feb 23, 2022
SuperLine
K213599
Dentium Co., Ltd.
Dental · 100d