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
145–168 of 1543
Cleared Jan 28, 2022
BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
K212533
Institut Straumann AG
Dental · 170d
Cleared Jan 07, 2022
EK Implants and Abutments System
K203360
Hiossen, Inc.
Dental · 417d
Cleared Jan 07, 2022
CORE1 Implant System
K210039
Cybermed, Inc.
Dental · 366d
Cleared Jan 05, 2022
Jplant
K211978
Jj Medical Co., Ltd.
Dental · 194d
Cleared Dec 21, 2021
TRI-matrix Implant Line
K203660
Tri Dental Implants Int. AG
Dental · 371d
Cleared Dec 21, 2021
N1 TiUltra TCC Implant System
K211109
Nobel Biocare Services AG
Dental · 251d
Cleared Dec 14, 2021
DESS Dental Implants
K212538
Terrats Medical SL
Dental · 124d
Cleared Nov 30, 2021
Paltop Narrow Implant
K210117
Paltop Advanced Dental Solutions, Ltd.
Dental · 315d
Cleared Nov 01, 2021
Alpha Dent Implants Dental Implants System
K210499
Alpha Dent Implants GmbH
Dental · 252d
Cleared Oct 20, 2021
S.I.N. Dental Implant System
K211921
S.I.N. ? Sistema DE Implante Nacional S.A.
Dental · 121d
Cleared Oct 15, 2021
Magicore System
K212517
Innobiosurg Co., Ltd.
Dental · 66d
Cleared Sep 30, 2021
Implanova
K210523
Dental Evolutions, Inc.
Dental · 219d
Cleared Sep 24, 2021
Nobel Biocare Dental Implant Systems Portfolio - MR Conditional
K212125
Nobel Biocare AG
Dental · 79d
Cleared Sep 23, 2021
ABC Dental Implant System
K202092
Abracadabra Implants , Ltd.
Dental · 422d
Cleared Aug 28, 2021
AnyOne External Implant System
K203554
Megagen Implant Co., Ltd.
Dental · 267d
Cleared Aug 27, 2021
PrimeTaper EV Dental Implant
K210610
Dentsply Sirona, Inc.
Dental · 179d
Cleared Aug 13, 2021
Neodent Implant System - Zirconia Implant System
K210336
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 189d
Cleared Jul 29, 2021
BTI Extra-Short Dental Implant System UnicCa
K202825
B.T.I. Biotechnology Institute, Sl.
Dental · 308d
Cleared Jul 08, 2021
Straumann RidgeFit Implants
K211052
Institut Straumann AG
Dental · 90d
Cleared Jul 06, 2021
NUVO CF Implant System
K203309
JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A.
Dental · 238d
Cleared Jun 23, 2021
S.I.N. Dental Implant System
K203725
S.I.N. ? Sistema DE Implante Nacional S.A.
Dental · 184d
Cleared Jun 22, 2021
AnyOne Onestage Implant System
K210161
Megagen Implant Co., Ltd.
Dental · 152d
Cleared Jun 21, 2021
Straumann BLX Implant System
K210855
Institut Straumann AG
Dental · 90d
Cleared Jun 18, 2021
Kontact Dental Implant System
K210220
Biotech Dental, Sas
Dental · 142d