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