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
217–240 of 1543
Cleared Feb 21, 2020
AR_N SLA Type Implant System
K190641
Biotem Co., Ltd.
Dental · 345d
Cleared Feb 20, 2020
SDS2.2 dental implant
K190406
Sds Swiss Dental Solutions AG
Dental · 364d
Cleared Feb 13, 2020
Implacil Implant System
K183024
Implacil DE Bortoli Material Odontologico Ltda
Dental · 469d
Cleared Feb 10, 2020
K3Pro Konus New Abutments and Implants
K190192
Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG
Dental · 371d
Cleared Feb 04, 2020
s-Clean SQ-SL Implant System Regular
K192688
Dentis Co., Ltd.
Dental · 131d
Cleared Jan 22, 2020
Internal Hex Implant System
K190837
Ebi, Inc.
Dental · 296d
Cleared Jan 03, 2020
Z5-BL
K190243
Z-Systems AG
Dental · 331d
Cleared Dec 27, 2019
Straumann BLX Ø3.5 mm Implants
K191256
Institut Straumann AG
Dental · 231d
Cleared Dec 16, 2019
EM Provisional
K191751
Hiossen, Inc.
Dental · 168d
Cleared Dec 11, 2019
MIS Dental Implant System
K192149
Dentsply Sirona, Inc.
Dental · 124d
Cleared Dec 09, 2019
Southern Implants MAX Implant System
K191054
Southern Implants (Pty), Ltd.
Dental · 234d
Cleared Dec 09, 2019
Straumann Mini Implants
K191895
Institut Straumann AG
Dental · 147d
Cleared Dec 06, 2019
JJ Implant System
K190552
Jj Implants
Dental · 276d
Cleared Nov 20, 2019
SDS1.2 dental implant
K181953
Sds Swiss Dental Solutions AG
Dental · 485d
Cleared Nov 15, 2019
EM SA Implant System
K191201
Hiossen, Inc.
Dental · 193d
Cleared Nov 14, 2019
ST Internal Implant System
K192347
Megagen Implant Co., Ltd.
Dental · 77d
Cleared Nov 09, 2019
Neodent Implant System
K190958
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 211d
Cleared Oct 29, 2019
W Zirconia Implants
K192053
Tav Medical , Ltd.
Dental · 90d
Cleared Oct 09, 2019
AnyRidge Octa 1 Implant System
K182448
Megagen Implant Co., Ltd.
Dental · 397d
Cleared Oct 08, 2019
Advanced Intermezzo Implant System
K191127
Megagen Implant Co., Ltd.
Dental · 162d
Cleared Oct 03, 2019
ALFA GATE Dental Implants System
K182143
Alfa Gate Mazen, Ltd.
Dental · 422d
Cleared Aug 29, 2019
SGS Dental Implants System
K182219
Sgs International, Ltd.
Dental · 379d
Cleared Aug 14, 2019
IS-III active System_S-narrow Type
K190849
Neobiotech Co., Ltd.
Dental · 135d
Cleared Jul 18, 2019
Ziacom Dental Implant Systems
K182908
Ziacom Medical, S.L.
Dental · 274d