ClearanceBrief
Panels › Dental › Product code DZE · Class 2

Implant, Endosseous, Root-Form

Regulation 872.3640

20510(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
Oct 22, 2026K261295MultiNeO Dental Implant System
Alpha Bio Tec , Ltd., IL
DZE
Sep 17, 2026K261392TriActive Dental Implant System
Paragon Implant Mfg., LLC
DZE
Aug 19, 2026K260463ZEROS Dental Implant System
Zeros Co., Ltd., KR
DZE
Jun 25, 2026K251188UNIQA® Dental Implants System
Uniqa Dental, Ltd., IL
DZE
Jun 18, 2026K251232MegaGen Zygoma Dental Implant System
Megagen Implant Co., Ltd., KR
DZE
Jun 18, 2026K250806Dental Implant System
A.B. Dental Devices , Ltd., IL
DZE
Jun 17, 2026K260006INOSS System
Inosys, Inc.
DZE
May 12, 2026K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant
Promimic AB, SE
DZE
Mar 23, 2026K252031Adin Long Dental Implant System
Adin Dental Implant Systems , Ltd., IL
DZE
Mar 16, 2026K253334ZENEX Implant System_Short (R-System)
Izenimplant Co., Ltd., KR
DZE
Mar 10, 2026K252168Straumann® BLC Implants - Indication Widening
Institut Straumann AG, CH
DZE
Mar 4, 2026K253493Dentis SQ-SL AXEL Fixture
Dentis Co., Ltd., KR
DZE
Feb 18, 2026K252197Nobel Biocare S Series Implants
Nobel Biocare AB, SE
DZE
Feb 2, 2026K252286BIORES Dental Implant System
Chengdu Besmile Medical Technology Co., Ltd., CN
DZE
Jan 8, 2026K252585ZENEX Implant System_R-System
Izenimplant Co., Ltd., KR
DZE
Dec 23, 2025K252145GEN5™ and GEN5+™ 3.3mmD Dental Implants
Paragon Implant Mfg., LLC
DZE
Dec 23, 2025K250476NizPlant Dental Implant System
Paragon Implant Mfg., LLC
DZE
Dec 22, 2025K251605DIMPLO Implant System
DIMPLO, Ltd., KR
DZE
Dec 12, 2025K252090Pterygoid Indication for GM Helix Implants
JJGC Indústria e Comércio de Materiais Dentários S.A., BR
DZE
Nov 7, 2025K251129S.I.N. Tapered Pro Conical Zygoma Implant System
S.I.N. Implant System Ltda, BR
DZE
Oct 30, 2025K251938GEN5 and GEN5+ Dental Implant System
Paragon Implant Mfg., LLC
DZE
Oct 10, 2025K243078HexaPLUS S OneDrill Implant System
Osseofuse International, Inc.
DZE
Sep 29, 2025K243983Paltop Dental Implant System
Paltop Advanced Dental Solutions, Ltd., IL
DZE
Sep 26, 2025K251262S.I.N. Dental Implant System
S.I.N. Implant System Ltda, BR
DZE
Sep 25, 2025K251148JDEvolution Plus L and JDEvolution Plus LE
Jdentalcare Srl, IT
DZE
Aug 25, 2025K243834NobelZygoma TiUltra Implant system
Nobel Biocare AB, SE
DZE
Aug 21, 2025K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Co
Dentsply Sirona, Inc.
DZE
Aug 18, 2025K250271Neodent Implant System - Zirconia Implant System
JJGC Indústria e Comércio de Materiais Dentários S.A., BR
DZE
Aug 13, 2025K251046S.I.N. Dental Implant System
S.I.N. Implant System Ltda, BR
DZE
Aug 12, 2025K250294Straumann® RidgeFit Implants
Institut Straumann AG, CH
DZE
Jul 24, 2025K251297MIS LYNX Conical Connection Implant System
Dentsply Sirona, Inc.
DZE
Jul 23, 2025K251280DESS® Dental Implants
Terrats Medical SL, ES
DZE
Jul 23, 2025K250280SD TL Implant System
Arum Dentistry Co., Ltd., KR
DZE
Jul 9, 2025K243731HEXIM Implant; Samwon General Abutments
P&A USA
DZE
Jul 3, 2025K243255URIS Long Implant & Abutments
Truabutment, Inc.
DZE
Jun 27, 2025K251660T3 Pro Implants– ZimVie Packaging System
Biomet 3i, LLC
DZE
Jun 18, 2025K250872Bioline Dental Implant System
Bioline Dental Implant Systems, Ltd., IL
DZE
Jun 6, 2025K243002MBA Biotech Implant System
MBA Biotech Co., Ltd., KR
DZE
May 14, 2025K242072CeraRoot TL Implant System (TL)
Ceraroot SL, ES
DZE
May 8, 2025K233271OsseOne Dental Implant System
Synoross Dba Osseone
DZE
Apr 21, 2025K250176DAND Dental Implant System
D.A.N.D. Metal Industries North, Ltd., IL
DZE
Feb 24, 2025K241703SD Implant System
Arum Dentistry Co., Ltd., KR
DZE
Feb 11, 2025K241462LONGY Implant and LONGY-N Implant
Noris Medical , Ltd., IL
DZE
Jan 29, 2025K242217Surcam Dental Implant System
Surcam Medical Devices and Developments, Ltd., IL
DZE
Jan 8, 2025K242661TRI-matrix® X-Force Implants
Tri Dental Implants Int. AG, CH
DZE
Jan 6, 2025K242753SD TL Implant System
Arum Dentistry Co., Ltd., KR
DZE
Dec 27, 2024K241972BLUEDIAMOND IMPLANT
Megagen Implant Co., Ltd., KR
DZE
Dec 27, 2024K241127INNO SLA Mini Plus® Implant System
Cowellmedi Co., Ltd., KR
DZE
Dec 20, 2024K240435Alpha Dent Implants Dental Implants System
Alpha Dent Implants GmbH, DE
DZE
Dec 19, 2024K243094Quickdent Dental Implant System
Quickdent Devices Private , Ltd., IN
DZE

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