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
25–48 of 1543
Cleared Jul 23, 2025
SD TL Implant System
K250280
Arum Dentistry Co., Ltd.
Dental · 173d
Cleared Jul 23, 2025
DESS® Dental Implants
K251280
Terrats Medical SL
Dental · 90d
Cleared Jul 09, 2025
HEXIM Implant
K243731
P&A USA
Dental · 217d
Cleared Jul 03, 2025
URIS Long Implant & Abutments
K243255
Truabutment, Inc.
Dental · 261d
Cleared Jun 27, 2025
T3 Pro Implants– ZimVie Packaging System
K251660
Biomet 3i, LLC
Dental · 28d
Cleared Jun 18, 2025
Bioline Dental Implant System
K250872
Bioline Dental Implant Systems, Ltd.
Dental · 86d
Cleared Jun 06, 2025
MBA Biotech Implant System
K243002
MBA Biotech Co., Ltd.
Dental · 253d
Cleared May 14, 2025
CeraRoot TL Implant System (TL)
K242072
Ceraroot SL
Dental · 302d
Cleared May 08, 2025
OsseOne Dental Implant System
K233271
Synoross Dba Osseone
Dental · 587d
Cleared Apr 21, 2025
DAND Dental Implant System
K250176
D.A.N.D. Metal Industries North, Ltd.
Dental · 89d
Cleared Feb 24, 2025
SD Implant System
K241703
Arum Dentistry Co., Ltd.
Dental · 256d
Cleared Feb 11, 2025
LONGY Implant and LONGY-N Implant
K241462
Noris Medical , Ltd.
Dental · 264d
Cleared Jan 29, 2025
Surcam Dental Implant System
K242217
Surcam Medical Devices and Developments, Ltd.
Dental · 184d
Cleared Jan 08, 2025
TRI-matrix® X-Force Implants
K242661
Tri Dental Implants Int. AG
Dental · 126d
Cleared Jan 06, 2025
SD TL Implant System
K242753
Arum Dentistry Co., Ltd.
Dental · 116d
Cleared Dec 27, 2024
INNO SLA Mini Plus® Implant System
K241127
Cowellmedi Co., Ltd.
Dental · 248d
Cleared Dec 27, 2024
BLUEDIAMOND IMPLANT
K241972
Megagen Implant Co., Ltd.
Dental · 175d
Cleared Dec 20, 2024
Alpha Dent Implants Dental Implants System
K240435
Alpha Dent Implants GmbH
Dental · 310d
Cleared Dec 19, 2024
Quickdent Dental Implant System
K243094
Quickdent Devices Private , Ltd.
Dental · 80d
Cleared Dec 16, 2024
Dental Implants and Abutments
K243066
Ditron Dental, Ltd.
Dental · 80d
Cleared Dec 10, 2024
Straumann® PURE Ceramic Implants
K241391
Institut Straumann AG
Dental · 209d
Cleared Nov 25, 2024
MIS LYNX Conical Connection Implant System
K241692
Dentsply Sirona, Inc.
Dental · 166d
Cleared Nov 15, 2024
NUVENTUS NV.C™ Dental Implant System
K233081
Infinitum Eta, Ltd.
Dental · 416d
Cleared Nov 07, 2024
LL Implant System
K242379
Ossvis Co., Ltd.
Dental · 87d