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
Jul 11, 2019
Zygomatic Implants
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental
113d
Cleared
Jul 08, 2019
PRAMA White Implant Systems
Sweden & Martina S.P.A.
Dental
511d
Cleared
Jul 08, 2019
Surgikor Dental Implant System
Surgikor, LLC
Dental
290d
Cleared
Jul 03, 2019
AlphaDent Implants Dental Implants System
Alphadent Implants, Ltd.
Dental
446d
Cleared
Jun 17, 2019
MRI Compatibility for Existing Straumann Dental Implant Systems
Straumann USA, LLC
Dental
94d
Cleared
May 24, 2019
Conical Plus Implant System
Osseofuse International, Inc.
Dental
388d
Cleared
May 21, 2019
ET IV SA Dental Implants
Hiossen, Inc.
Dental
181d
Cleared
Mar 29, 2019
Reflect Implant System
Ids - Integrated Dental Systems
Dental
354d
Cleared
Mar 11, 2019
BoneTrust Implant System
Medical Instinct Deutschland GmbH
Dental
196d
Cleared
Feb 21, 2019
NobelParallel Conical Connection
Nobel Biocare AB
Dental
477d
Cleared
Feb 15, 2019
OsseOne Dental Implant System
Synoross Dba Osseone
Dental
175d
Cleared
Jan 24, 2019
Ritter Dental Implant System
Ritter Implants GmbH CO KG
Dental
366d
Cleared
Jan 18, 2019
MRI Compatibility for Existing Neodent Implant System
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental
116d
Cleared
Jan 04, 2019
Straumann PURE Ceramic Implant System
Institut Straumann AG
Dental
316d
Cleared
Dec 28, 2018
Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments
Institut Straumann AG
Dental
184d
Cleared
Dec 14, 2018
UV Active Implant System
Dio Corporation
Dental
122d
Cleared
Dec 13, 2018
PYRAMIDION Dental Implants and Prostheses
Dentack Implants, Ltd.
Dental
255d
Cleared
Dec 04, 2018
NobelZygoma 0°
Nobel Biocare AB
Dental
29d
Cleared
Nov 29, 2018
Implant-One System
Implant Logistics, Inc.
Dental
360d
Cleared
Nov 16, 2018
IT-III active System
Neobiotech Co., Ltd.
Dental
200d
Cleared
Nov 14, 2018
Inversa Implants
Southern Implants (Pty), Ltd.
Dental
126d
Cleared
Nov 06, 2018
W Zirconia Implants
Tav Medical , Ltd.
Dental
427d
Cleared
Nov 01, 2018
Implantswiss Dental Implant System, Implantswiss Dental Abutment System
Novodent SA
Dental
171d
Cleared
Oct 26, 2018
Biomate Dental Implant System
Biomate Medical Devices Technology Co., Ltd.
Dental
595d