ClearanceBrief
Panels › Dental › Product code DZE · Class 2

Implant, Endosseous, Root-Form

Regulation 872.3640

19510(k)s in 12 months (1,550 all time)
2recalls in 12 months (212 all time)
192recalls that name a 510(k)
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Top companies in DZE

Company510(k)sRecalls
Nobel Biocare AB3337
Biomet 3i1152
Nobelpharma AB520
Zimmer Dental, Inc.1930
Straumann USA359
Implant Innovations, Inc.374
Steri-Oss, Inc.400
BioHorizons Implant Systems, Inc.2612
Minimatic Implant Technology340
Implant Center of the Palm Beaches320
Decided510(k)Device and applicantCode
Feb 23, 2022K213599SuperLine
Dentium Co., Ltd., KR
DZE
Jan 28, 2022K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
Institut Straumann AG, CH
DZE
Jan 7, 2022K210039CORE1 Implant System
Cybermed, Inc., KR
DZE
Jan 7, 2022K203360EK Implants and Abutments System
Hiossen, Inc.
DZE
Jan 5, 2022K211978Jplant
Jj Medical Co., Ltd., KR
DZE
Dec 21, 2021K211109N1 TiUltra TCC Implant System
Nobel Biocare Services AG, CH
DZE
Dec 21, 2021K203660TRI-matrix Implant Line
Tri Dental Implants Int. AG, CH
DZE
Dec 14, 2021K212538DESS Dental Implants
Terrats Medical SL, ES
DZE
Nov 30, 2021K210117Paltop Narrow Implant
Paltop Advanced Dental Solutions, Ltd., IL
DZE
Nov 1, 2021K210499Alpha Dent Implants Dental Implants System
Alpha Dent Implants GmbH, DE
DZE
Oct 20, 2021K211921S.I.N. Dental Implant System
S.I.N. - Sistema DE Implante Nacional S.A., BR
DZE
Oct 15, 2021K212517Magicore System
Innobiosurg Co., Ltd., KR
DZE
Sep 30, 2021K210523Implanova
Dental Evolutions, Inc.
DZE
Sep 24, 2021K212125Nobel Biocare Dental Implant Systems Portfolio - MR Conditional
Nobel Biocare AG, CH
DZE
Sep 23, 2021K202092ABC Dental Implant System
Abracadabra Implants , Ltd., IL
DZE
Aug 28, 2021K203554AnyOne External Implant System
Megagen Implant Co., Ltd., KR
DZE
Aug 27, 2021K210610PrimeTaper EV Dental Implant
Dentsply Sirona, Inc.
DZE
Aug 13, 2021K210336Neodent Implant System - Zirconia Implant System
Jjgc Industria E Comercio DE Materiais Dentarios S.A., BR
DZE
Jul 29, 2021K202825BTI Extra-Short Dental Implant System UnicCa
B.T.I. Biotechnology Institute, Sl., ES
DZE
Jul 8, 2021K211052Straumann RidgeFit Implants
Institut Straumann AG, CH
DZE
Jul 6, 2021K203309NUVO CF Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A., BR
DZE
Jun 23, 2021K203725S.I.N. Dental Implant System
S.I.N. - Sistema DE Implante Nacional S.A., BR
DZE
Jun 22, 2021K210161AnyOne Onestage Implant System
Megagen Implant Co., Ltd., KR
DZE
Jun 21, 2021K210855Straumann BLX Implant System
Institut Straumann AG, CH
DZE
Jun 18, 2021K210220Kontact Dental Implant System
Biotech Dental, Sas, FR
DZE
Jun 17, 2021K210886MIS Lance+ Conical Connection Dental Implant System
Dentsply Sirona
DZE
Jun 4, 2021K210080Dentis s-Clean s-Line Mini
Dentis Co., Ltd., KR
DZE
May 26, 2021K202832Implacil Implant System
Implacil DE Bortoli Material Odontologico Ltda, BR
DZE
May 14, 2021K200573BoneTrust Mini Implant System
Medical Instinct Deutschland GmbH, DE
DZE
Apr 22, 2021K200329IDCAM Dental Implants
Implants Diffusion International, FR
DZE
Apr 19, 2021K210134Dentis s-Clean s-Line
Dentis Co., Ltd., KR
DZE
Apr 15, 2021K203701Locator Overdenture Implant System
Ivory Super Holdco Inc. / Zest Anchors, LLC
DZE
Mar 18, 2021K202773s-Clean SQ-SL Implant System Mini
Dentis Co., Ltd., KR
DZE
Mar 15, 2021K203382Neodent Implant System-Easy Pack
Jjgc Industria E Comercio DE Materiais Dentarios S.A., BR
DZE
Feb 17, 2021K210132s-Clean SQ-SL Implant System Regular
Dentis Co., Ltd., KR
DZE
Feb 11, 2021K192839DSP Implant System
D.S.P Industrial Eireli, BR
DZE
Feb 8, 2021K202942Straumann 4 mm Short Implants
Straumann USA, LLC
DZE
Jan 22, 2021K201553Simply Iconic Implants
Implant Direct Sybron Manufacturing, LLC
DZE
Jan 13, 2021K201700BEGO Semados® RS/RSX Implant System
Bego Implant Systems GmbH & Co. KG, DE
DZE
Dec 22, 2020K201491Neodent Implant System - Zirconia Implant System
Jjgc Industria E Comercio DE Materiais Dentarios S.A., BR
DZE
Dec 1, 2020K201712Z5-TL
Z-Systems AG, CH
DZE
Nov 17, 2020K200992S.I.N. Dental Implant System
S.I.N. - Sistema DE Implante Nacional S.A., BR
DZE
Nov 16, 2020K202344TiUltra Implants and Xeal Abutments
Nobel Biocare AB, SE
DZE
Nov 10, 2020K183044JTK Dental Implant System
Jiangyin Jintech Biotech Co., Ltd., CN
DZE
Oct 20, 2020K181477MS Lide Implant Systems
Hangzhou Minsheng Lide Medical Science & Technology Co., Ltd., CN
DZE
Oct 16, 2020K200906MINICONE Implant
Medentika GmbH, DE
DZE
Oct 14, 2020K200386Z5-BL
Z-Systems AG, CH
DZE
Oct 7, 2020K200817URIS OMNI Narrow System & Prosthetic
Truabutment, Inc.
DZE
Sep 29, 2020K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants
Altatec GmbH, DE
DZE
Sep 25, 2020K202039Honorst Implant System
Medimecca Co., Ltd., KR
DZE

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