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
Sep 23, 2023K222778Osstem Implant System
Osstem Implant Co., Ltd., KR
DZE
Sep 14, 2023K230108Straumann® BLC and TLC Implants
Institut Straumann AG, CH
DZE
Aug 23, 2023K222946Oneday Mini Implant System
Oneday Biotech Co., Ltd., KR
DZE
Aug 8, 2023K223924LW Implant System
Ossvis Co., Ltd., KR
DZE
Jul 31, 2023K230630ZENEX Implant System_Narrow
Izenimplant Co., Ltd., KR
DZE
Jul 18, 2023K223339Bone Chamber Implant
Megagen Implant Co., Ltd., KR
DZE
Jul 7, 2023K222707IH Implant System
Sewonmedix, Inc., KR
DZE
Jul 1, 2023K230725NB Implant System
Arum Dentistry Co., Ltd., KR
DZE
Jun 26, 2023K221488Z7 Zirconia Implant System
Z7, LLC
DZE
Jun 24, 2023K222142BR SLA Type Implant System
Biotem Co., Ltd., KR
DZE
Jun 23, 2023K223638Neodent Implant System - Helix Short Implant System
Jjgc Industria E Comercio DE Materiais Dentarios S.A., BR
DZE
Jun 22, 2023K223083Straumann SLActive labeling changes
Institut Straumann AG, CH
DZE
Jun 14, 2023K222144IR SLA Type Implant System
Biotem Co., Ltd., KR
DZE
Jun 8, 2023K222792SNUCONE Tissue Level Implant System
Snucone Co., Ltd., KR
DZE
Jun 4, 2023K221752Stella
Shinhung Mst Co., Ltd., KR
DZE
May 25, 2023K223814Genesis ACTIVE Implant System
Keystone Dental, Inc.
DZE
Apr 13, 2023K222738Point implant system
Pointnix Co., Ltd., KR
DZE
Mar 6, 2023K222457Provata Implant System
Southern Implants (Pty), Ltd., ZA
DZE
Feb 2, 2023K222211Implant Direct Dental Implant Systems Portfolio - MR Conditional
Implant Direct Sybron Manufacturing, LLC
DZE
Jan 13, 2023K221317S-Mono
Shinhung Mst Co., Ltd., KR
DZE
Jan 6, 2023K211812BLUEDIAMOND IMPLANT, Abutment Screw
Megagen Implant Co., Ltd., KR
DZE
Dec 20, 2022K220517IBS System
Innobiosurg Co., Ltd., KR
DZE
Dec 20, 2022K213677Bonafix 2 Plus
Zentek Medical, LLC
DZE
Dec 15, 2022K221453S.I.N. Dental Implant System
S.I.N. – Sistema DE Implante Nacional S.A., BR
DZE
Dec 14, 2022K221910QRS Dental Implants System
Qrs Medical , Ltd., IL
DZE
Dec 14, 2022K220079Magicore Narrow System
Innobiosurg Co., Ltd., KR
DZE
Nov 16, 2022K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connection
Dentsply Sirona
DZE
Nov 16, 2022K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)
Dentsply Sirona
DZE
Nov 9, 2022K222497Zaga Zygomatic System
Southern Implants (Pty), Ltd., ZA
DZE
Oct 27, 2022K222231S.I.N. Dental Implant System
S.I.N. - Sistema DE Implante Nacional S.A., BR
DZE
Oct 19, 2022K211409Proximerge 2 Dental Implant System
Quadric Biomed, LLC
DZE
Oct 13, 2022K212702IM/ST Fixture System
Guilin Fiteeth Medical Instrument Co., Ltd., CN
DZE
Sep 19, 2022K222131NB 1 SA Implant System
Arum Dentistry Co., Ltd., KR
DZE
Sep 14, 2022K220978TSX Implants
Biomet 3i, LLC
DZE
Sep 6, 2022K220251Neodent Implant System - GM Narrow Implant System
Jjgc Industria E Comercio DE Materiais Dentarios S.A., BR
DZE
Aug 10, 2022K212364BLT Dental Implant System
Bio Concept Co., Ltd., CN
DZE
Jul 21, 2022K211952BTI Interna Narrow/Plus Dental Implant System UnicCa
B.T.I. Biotechnology Institute, Sl., ES
DZE
Jul 15, 2022K213997Kontact Dental Implant System
Biotech Dental, Sas, FR
DZE
Jul 15, 2022K213576Tatum Surgical Dental Implant System
Suncoast Dental, Inc. Dba Tatum Surgical
DZE
Jul 13, 2022K210354SNUCONE Bone Level Implant System
Snucone Co., Ltd., KR
DZE
Jul 8, 2022K212775Adin Short Implants
Adin Dental Implants Systems , Ltd., IL
DZE
Jun 30, 2022K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments
Blue Sky Bio, LLC
DZE
Jun 24, 2022K210852Noris Medical Dental Implants System - Cortical
Noris Medical , Ltd., IL
DZE
May 25, 2022K220200Paltop Conical Implant System
Paltop Advanced Dental Solutions, Ltd., IL
DZE
Apr 13, 2022K211090ZENEX Implant System
Izenimplant Co., Ltd., KR
DZE
Apr 6, 2022K213506NB 1 SA Implant System
Arum Dentistry Co., Ltd., KR
DZE
Apr 4, 2022K220022TRATE Dental Implant System
Trate AG, CH
DZE
Mar 28, 2022K213672T3 Pro Implants
Biomet 3i, LLC
DZE
Mar 17, 2022K210489SICtapered & SICvantage tapered
Sic Invent AG, CH
DZE
Mar 1, 2022K202046LOTA SLA Dental Implant System and LOTA HA Dental Implant System
Kj Meditech Co., Ltd., KR
DZE

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