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
241–264 of 1543
Cleared Jul 11, 2019
Zygomatic Implants
K190718
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 113d
Cleared Jul 08, 2019
PRAMA White Implant Systems
K180365
Sweden & Martina S.P.A.
Dental · 511d
Cleared Jul 08, 2019
Surgikor Dental Implant System
K182615
Surgikor, LLC
Dental · 290d
Cleared Jul 03, 2019
AlphaDent Implants Dental Implants System
K180968
Alphadent Implants, Ltd.
Dental · 446d
Cleared Jun 17, 2019
MRI Compatibility for Existing Straumann Dental Implant Systems
K190662
Straumann USA, LLC
Dental · 94d
Cleared May 24, 2019
Conical Plus Implant System
K181157
Osseofuse International, Inc.
Dental · 388d
Cleared May 21, 2019
ET IV SA Dental Implants
K183242
Hiossen, Inc.
Dental · 181d
Cleared Mar 29, 2019
Reflect Implant System
K180924
Ids - Integrated Dental Systems
Dental · 354d
Cleared Mar 11, 2019
BoneTrust Implant System
K182313
Medical Instinct Deutschland GmbH
Dental · 196d
Cleared Feb 21, 2019
NobelParallel Conical Connection
K173418
Nobel Biocare AB
Dental · 477d
Cleared Feb 15, 2019
OsseOne Dental Implant System
K182293
Synoross Dba Osseone
Dental · 175d
Cleared Jan 24, 2019
Ritter Dental Implant System
K180183
Ritter Implants GmbH CO KG
Dental · 366d
Cleared Jan 18, 2019
MRI Compatibility for Existing Neodent Implant System
K182620
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 116d
Cleared Jan 04, 2019
Straumann PURE Ceramic Implant System
K180477
Institut Straumann AG
Dental · 316d
Cleared Dec 28, 2018
Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments
K181703
Institut Straumann AG
Dental · 184d
Cleared Dec 14, 2018
UV Active Implant System
K182194
Dio Corporation
Dental · 122d
Cleared Dec 13, 2018
PYRAMIDION Dental Implants and Prostheses
K180859
Dentack Implants, Ltd.
Dental · 255d
Cleared Dec 04, 2018
NobelZygoma 0°
K183069
Nobel Biocare AB
Dental · 29d
Cleared Nov 29, 2018
Implant-One System
K173701
Implant Logistics, Inc.
Dental · 360d
Cleared Nov 16, 2018
IT-III active System
K181137
Neobiotech Co., Ltd.
Dental · 200d
Cleared Nov 14, 2018
Inversa Implants
K181850
Southern Implants (Pty), Ltd.
Dental · 126d
Cleared Nov 06, 2018
W Zirconia Implants
K172668
Tav Medical , Ltd.
Dental · 427d
Cleared Nov 01, 2018
Implantswiss Dental Implant System, Implantswiss Dental Abutment System
K181266
Novodent SA
Dental · 171d
Cleared Oct 26, 2018
Biomate Dental Implant System
K170732
Biomate Medical Devices Technology Co., Ltd.
Dental · 595d