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
Dec 16, 2024K243066Dental Implants and Abutments
Ditron Dental, Ltd., IL
DZE
Dec 10, 2024K241391Straumann® PURE Ceramic Implants
Institut Straumann AG, CH
DZE
Nov 25, 2024K241692MIS LYNX Conical Connection Implant System
Dentsply Sirona, Inc.
DZE
Nov 15, 2024K233081NUVENTUS NV.C™ Dental Implant System
Infinitum Eta, Ltd., IL
DZE
Nov 7, 2024K242379LL Implant System
Ossvis Co., Ltd., KR
DZE
Nov 6, 2024K242261Accelx Implant System
Biotech Dental, LLC
DZE
Oct 31, 2024K240383Highness Implant System
Highness Co., Ltd., KR
DZE
Oct 30, 2024K240560ZENEX Implant System_Long
Izenimplant Co., Ltd., KR
DZE
Oct 23, 2024K241753Immediate Molar Implants
Biomet 3i, LLC
DZE
Oct 11, 2024K240143JDZygoma dental implants
Jdentalcare Srl, IT
DZE
Oct 10, 2024K240262BTI Interna 3.0 Dental Implant System UnicCa®
B.T.I. Biotechnology Institute, Sl., ES
DZE
Sep 13, 2024K240977DenQ Sub SLA Implant System
Denq, KR
DZE
Sep 13, 2024K240232EK D3.3 and Ultra Wide Implants
Hiossen, Inc.
DZE
Sep 12, 2024K240803Surgikor Fixation One, Abutment Blanks and Abutments
Surgikor, LLC
DZE
Sep 5, 2024K231566ICX-Implant System
Medentis Medical GmbH, DE
DZE
Aug 23, 2024K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw
Proimtech Saglik Urunleri Anonim Sirketi, TR
DZE
Aug 16, 2024K233896JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus
Jdentalcare Srl, IT
DZE
Aug 15, 2024K240837TOV Dental Implant System
Rdj Tov Implant, Ltd., IL
DZE
Jul 31, 2024K233808LW Narrow Implant System
Ossvis Co., Ltd., KR
DZE
Jul 17, 2024K240609S.I.N. Dental Implant System
S.I.N. - Sistema DE Implante Nacional S.A., BR
DZE
Jul 9, 2024K240966Prima Plus Conical Implant System
Keystone Dental, Inc.
DZE
Jun 6, 2024K240202Conical Platform Dental Implants System
Noris Medical , Ltd., IL
DZE
Jun 5, 2024K240187Tapered Pro Conical Implant System
BioHorizons Implant Systems, Inc.
DZE
May 31, 2024K232821S.I.N. Dental Implant System
S.I.N. - Sistema DE Implante Nacional S.A., BR
DZE
May 24, 2024K2314268plant Implant System
Hoowon Edi Co., Ltd., KR
DZE
May 22, 2024K232740Paltop Short Implants
Paltop Advanced Dental Solutions, Ltd., IL
DZE
May 20, 2024K240511Dentis s-Clean SQ-SL Fixture
Dentis Co., Ltd., KR
DZE
May 16, 2024K233137Ticare Dental Implant Systems
Mozograu S.A., ES
DZE
Apr 30, 2024K233231Dental Implants and Abutments
Ditron Dental, Ltd., IL
DZE
Apr 26, 2024K240091NB Mini Implant System
Arum Dentistry Co., Ltd., KR
DZE
Apr 11, 2024K221847Ni2 Implant System
Newton Implant Systems, Inc.
DZE
Apr 1, 2024K232726External Hex Implant System
Southern Implants (Pty), Ltd., ZA
DZE
Mar 28, 2024K232049IS-III active Short Implant
Neobiotech Co., Ltd., KR
DZE
Mar 25, 2024K232268STERI-OSS Implant System
Zeros Co., Ltd., KR
DZE
Mar 20, 2024K234049Straumann® BLC and TLC Implants - Line extension
Institut Straumann AG, CH
DZE
Jan 18, 2024K221866S-Plant Dental Implant System
Newton Implant Systems, Inc.
DZE
Dec 29, 2023K230438URIS Smart Path Implant System & Prosthetic
Truabutment, Inc.
DZE
Dec 29, 2023K223714UniFit Dental Implant System
Adin Dental Implant Systems , Ltd., IL
DZE
Dec 19, 2023K233163ZENEX Implant System_Short
Izenimplant Co., Ltd., KR
DZE
Dec 18, 2023K231429S-Plant Dental Implant System
Idis Co., Ltd., KR
DZE
Dec 7, 2023K231967ARi ExCon Implant System
Megagen Implant Co., Ltd., KR
DZE
Dec 7, 2023K231127S.I.N. Dental Implant System
S.I.N. - Sistema DE Implante Nacional S.A., BR
DZE
Dec 1, 2023K232418Single Platform SP1 Implant System
Southern Implants (Pty), Ltd., ZA
DZE
Oct 31, 2023K232099Neodent Implant System - GM Zygomatic Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A., BR
DZE
Oct 25, 2023K221315UNIdental Symphony Implant System
Unidental Co., Ltd., KR
DZE
Oct 18, 2023K231395INNO SLA Submerged Narrow Implant System
Cowellmedi Co., Ltd., KR
DZE
Oct 16, 2023K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL
Anthogyr, FR
DZE
Oct 13, 2023K223697MRI compatibility for existing BioHorizons dental implants and abutments
BioHorizons Implant Systems, Inc.
DZE
Oct 11, 2023K230618MegaGen Dental Implant Systems Portfolio - MR Conditional
Megagen Implant Co., Ltd., KR
DZE
Oct 5, 2023K230242OsteoCentric Dental Implant System
OsteoCentric Technologies
DZE

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