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
Jan 31, 2018K171297AR_N Type Implant System
Biotem Co., Ltd., KR
DZE
Jan 19, 2018K171784Straumann Dental Implant System
Straumann USA, LLC
DZE
Dec 28, 2017K172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments
Mis Implants Technologies , Ltd., IL
DZE
Dec 21, 2017K172560PREMIUM ONE Implant Systems
Sweden & Martina S.P.A., IT
DZE
Dec 1, 2017K171185IR Type Implant System
Biotem Co., Ltd., KR
DZE
Dec 1, 2017K170392S.I.N. Implant System
S.I.N. – Sistema DE Implante Nacional S.A., BR
DZE
Nov 22, 2017K172576BioHorizons Tapered Short Implants
BioHorizons Implant Systems, Inc.
DZE
Nov 21, 2017K170398S.I.N. Dental Implant System
S.I.N. – Sistema DE Implante Nacional S.A., BR
DZE
Nov 14, 2017K171769Straumann PURE Ceramic Implants
Straumann USA, LLC (On Behalf of Institut Straumann Ag)
DZE
Nov 9, 2017K161923J2A SLA Dental Implant System
Kj Meditech Co., Ltd., KR
DZE
Nov 6, 2017K163634External Hex Implants
Southern Implants (Pty), Ltd., ZA
DZE
Oct 20, 2017K172352TREFOIL System
Nobel Biocare AB, SE
DZE
Oct 6, 2017K170394Kisses Mini
Achimhai Medical Corporation, KR
DZE
Sep 29, 2017K171795Thommen Implant System
Thommen Medical AG, CH
DZE
Sep 28, 2017K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm
Sterngold Dental, LLC
DZE
Sep 15, 2017K162482A.B. DENTAL DEVICES Dental Implants System
A.B. Dental Device , Ltd., IL
DZE
Sep 7, 2017K171126Implantium II
Dentium Co., Ltd., KR
DZE
Sep 6, 2017K171027Dentis Dental Implant System
Dentis Co., Ltd., KR
DZE
Aug 31, 2017K170031Internal Octa Implant System
Ebi, Inc., KR
DZE
Aug 29, 2017K163385Cortex Dental Implant System
Cortex Dental Implants Industries , Ltd., IL
DZE
Aug 4, 2017K160850Nucleoss Tpure Implant System
Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti, TR
DZE
Jul 26, 2017K162867MagDen Dental Implant System
Shinhung Mst Co., Ltd., KR
DZE
Jul 14, 2017K163194Neodent Implant System - GM Line
Jjgc Industria E Comercio DE Materiais Dentarios S.A., BR
DZE
Jul 14, 2017K162853Bonafix TWO - Dental Implant System
Bonafix Surgical and Dental Implants
DZE
Jun 30, 2017K170372SpiralTech Dental Implant System
Spiraltech Superior Dental Implants, Inc.
DZE
Jun 22, 2017K162299Spiral Shape Dental Implant System
Gp Implants, IL
DZE
Jun 15, 2017K161177Axiom PX
Anthogyr Sas, FR
DZE
Jun 13, 2017K163060Deep Conical (DC) Implants and Accessories
Southern Implants (Pty), Ltd., ZA
DZE
May 26, 2017K163349MIS V3 Conical Connection Dental Implant System­
Mis Implants Technologies , Ltd., IL
DZE
May 24, 2017K170287Dental Implants OKTAGON Bone Level Tapered Design
Hager& Meisinger GmbH, DE
DZE
May 17, 2017K160398MRI Compatibility for Existing Zimmer Dental Implant Systems
Zimmer Dental, Inc.
DZE
May 15, 2017K163557SS SA Fixture
Osstem Implant Co., Ltd., KR
DZE
May 11, 2017K170135TREFOIL System
Nobel Biocare AB, SE
DZE
May 3, 2017K163640QZA and RS Dental Implant Systems
Trinon Titanium GmbH, DE
DZE
Apr 27, 2017K170220OneQ-SL s-Clean Implant System
Dentis Co., Ltd., KR
DZE
Apr 27, 2017K170211Insight Dental System
Insight Dental System
DZE
Apr 21, 2017K163088TSIII BA Fixture
Osstem Implant Co., Ltd., KR
DZE
Apr 14, 2017K161743Etgar Dental Implant System
Etgar Medical Instruments, Ltd., IL
DZE
Mar 24, 2017K160581K3PRO Konus Additional Abutments and Implants
Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG, DE
DZE
Mar 17, 2017K162308Noris Medical MBI-2mm Dental Implant System
Noris Medical , Ltd., IL
DZE
Mar 14, 2017K161598NobelZygoma 0°
Nobel Biocare AB, SE
DZE
Mar 8, 2017K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase A
Straumann USA, LLC
DZE
Feb 24, 2017K162073Dental Implants OKTAGON Tissue Level and Bone Level
Hager& Meisinger GmbH, DE
DZE
Feb 21, 2017K161987UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure
Dio Corporation, KR
DZE
Feb 15, 2017K162099IBS Implant System II
Innobiosurg Co., Ltd., KR
DZE
Feb 2, 2017K161103US SA Implant System
Osstem Implant Co., Ltd., KR
DZE
Jan 19, 2017K161593GMI Frontier Dental Implant System
Ilerimplant S.L, ES
DZE
Jan 13, 2017K160965SuperLine
Dentium Co., Ltd., KR
DZE
Jan 11, 2017K161281Dentalis Bio Solution Implants
Dentalis Bio Solution Implants, LLC
DZE
Jan 5, 2017K160536Chaorum Implant System
Medimecca Co., Ltd., KR
DZE

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