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