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
265–288 of 1543
Cleared Oct 10, 2018
BioHorizons Tapered IM Implants
K182070
BioHorizons Implant Systems, Inc.
Dental · 70d
Cleared Oct 03, 2018
IS-III active System
K181138
Neobiotech Co., Ltd.
Dental · 156d
Cleared Sep 19, 2018
CSM Submerged3-L Implant System
K173141
Csm Implant
Dental · 355d
Cleared Sep 06, 2018
Provata Implant System
K180465
Southern Implants (Pty), Ltd.
Dental · 197d
Cleared Aug 30, 2018
Neodent Implant System – GM Line
K180536
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 183d
Cleared Aug 17, 2018
BTI Dental Implant System UnicCa
K173257
B.T.I. Biotechnology Institute, Sl.
Dental · 311d
Cleared Aug 17, 2018
OsteoReady Dental Implant System
K173575
Osteoready, LLC
Dental · 270d
Cleared Aug 09, 2018
MyPlant II Implant System
K173819
Hager& Meisinger GmbH
Dental · 234d
Cleared Aug 08, 2018
UNIQA Dental Implants System
K180598
Uniqa Dental, Ltd.
Dental · 154d
Cleared Jul 24, 2018
S-mini active Fixture
K181178
Neobiotech Co., Ltd.
Dental · 83d
Cleared Jun 30, 2018
Zuga Dental Implant System
K171197
Zuga Medical, Inc.
Dental · 432d
Cleared Jun 28, 2018
KJ ZIRCONIA Implant System
K173116
Kj Meditech Co., Ltd.
Dental · 272d
Cleared Jun 22, 2018
MIS Internal Hex Dental Implant System
K180282
Mis Implants Technologies , Ltd.
Dental · 142d
Cleared Jun 18, 2018
IU Implant System
K172345
Warantec Co., Ltd.
Dental · 320d
Cleared Jun 11, 2018
Ti-one 101 TS Dental Implant System
K172821
Hung Chun Bio-S Co., Ltd.
Dental · 266d
Cleared Jun 08, 2018
Piccolo Implants and Accessories
K173706
Southern Implants (Pty), Ltd.
Dental · 186d
Cleared Jun 05, 2018
Straumann BLX Implant System
K173961
Institut Straumann AG
Dental · 159d
Cleared Jun 01, 2018
UF(II) Wide Fixture
K173975
Dio Corporation
Dental · 154d
Cleared May 24, 2018
IS-III HActive Fixture
K173938
Neobiotech Co., Ltd.
Dental · 149d
Cleared May 10, 2018
OKTAGON Implant System
K180360
Hager& Meisinger GmbH
Dental · 90d
Cleared May 04, 2018
URIS OMNI System
K172100
Truabutment, Inc.
Dental · 297d
Cleared Apr 10, 2018
DTI-1 SLA IMPLANT SYSTEM
K170776
Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi
Dental · 392d
Cleared Apr 05, 2018
SIC invent Dental Implant Systems
K173207
Sic Invent AG
Dental · 185d
Cleared Apr 03, 2018
Kisses Plus Implant System
K172630
Achimhai Medical Corporation
Dental · 214d