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510(k) Predicate Database
Product code DZEClass 2

Implant, Endosseous, Root-Form 510(k) Clearances

Product code DZE is the FDA classification for Implant, Endosseous, Root-Form, a Class 2 device regulated under 21 CFR 872.3640, reviewed by the FDA Dental panel. FDA has cleared 1,547 510(k) submissions under this product code.

Devices under product code DZEshare an FDA classification category, but product-code overlap does not establish the same intended use, technological characteristics, or legal predicate eligibility. Treat this list as a screening cohort and review each device's indications, labeling, substantial-equivalence summary, and current legal-marketing status.

Cleared devices
1,547
Device class
Class 2
Regulation
872.3640
Latest clearance

Cleared devices under product code DZE

Showing the 50 most recent of 1,547 cleared devices. Clearances from 2024-11-25 to 2026-06-25.

FDA-cleared devices under product code DZE
510(k)DeviceApplicantDecision date
K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.
K250806Dental Implant SystemA.B. Dental Devices , Ltd.
K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.
K260006INOSS SystemInosys, Inc.
K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic AB
K252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.
K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.
K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG
K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.
K252197Nobel Biocare S Series ImplantsNobel Biocare AB
K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.
K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.
K250476NizPlant Dental Implant SystemParagon Implant Mfg., LLC
K252145GEN5™ and GEN5+™ 3.3mmD Dental ImplantsParagon Implant Mfg., LLC
K251605DIMPLO Implant SystemDIMPLO, Ltd.
K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.
K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda
K251938GEN5 and GEN5+ Dental Implant SystemParagon Implant Mfg., LLC
K243078HexaPLUS S OneDrill Implant SystemOsseofuse International, Inc.
K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.
K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda
K251148JDEvolution Plus L and JDEvolution Plus LEJdentalcare Srl
K243834NobelZygoma TiUltra Implant systemNobel Biocare AB
K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection SystemDentsply Sirona, Inc.
K250271Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.
K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda
K250294Straumann® RidgeFit ImplantsInstitut Straumann AG
K251297MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.
K250280SD TL Implant SystemArum Dentistry Co., Ltd.
K251280DESS® Dental ImplantsTerrats Medical SL
K243731HEXIM Implant; Samwon General AbutmentsP&A USA
K243255URIS Long Implant & AbutmentsTruabutment, Inc.
K251660T3 Pro Implants– ZimVie Packaging SystemBiomet 3i, LLC
K250872Bioline Dental Implant SystemBioline Dental Implant Systems, Ltd.
K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.
K242072CeraRoot TL Implant System (TL)Ceraroot SL
K233271OsseOne Dental Implant SystemSynoross Dba Osseone
K250176DAND Dental Implant SystemD.A.N.D. Metal Industries North, Ltd.
K241703SD Implant SystemArum Dentistry Co., Ltd.
K241462LONGY Implant and LONGY-N ImplantNoris Medical , Ltd.
K242217Surcam Dental Implant SystemSurcam Medical Devices and Developments, Ltd.
K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG
K242753SD TL Implant SystemArum Dentistry Co., Ltd.
K241127INNO SLA Mini Plus® Implant SystemCowellmedi Co., Ltd.
K241972BLUEDIAMOND IMPLANTMegagen Implant Co., Ltd.
K240435Alpha Dent Implants Dental Implants SystemAlpha Dent Implants GmbH
K243094Quickdent Dental Implant SystemQuickdent Devices Private , Ltd.
K243066Dental Implants and AbutmentsDitron Dental, Ltd.
K241391Straumann® PURE Ceramic ImplantsInstitut Straumann AG
K241692MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.

Filing a 510(k) for a Implant, Endosseous, Root-Form of this type?

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