DZE

Implant, Endosseous, Root-Form

Product code
DZE
Device name
Implant, Endosseous, Root-Form
Device class
Class 2
21 CFR
21 CFR 872.3640
Medical specialty
Dental
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
100
Summaries archived here
87 (direct download)
510(k) clearances (all years, FDA)
1548 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (100)

Last three years. Most recent: 2026-08-19.

NumberDecision dateApplicantDevice nameSummary
K2604632026-08-19Zeros Co., Ltd.ZEROS Dental Implant SystemPDF
K2511882026-06-25Uniqa Dental, Ltd.UNIQA® Dental Implants SystemPDF
K2512322026-06-18Megagen Implant Co., Ltd.MegaGen Zygoma Dental Implant SystemPDF
K2508062026-06-18A.B. Dental Devices , Ltd.Dental Implant System
K2600062026-06-17Inosys, Inc.INOSS SystemPDF
K2527312026-05-12Promimic ABPromimic ZrP Surface Dental Implant; Promimic ZrP + FDA
K2520312026-03-23Adin Dental Implant Systems , Ltd.Adin Long Dental Implant SystemPDF
K2533342026-03-16Izenimplant Co., Ltd.ZENEX Implant System_Short (R-System)PDF
K2521682026-03-10Institut Straumann AGStraumann® BLC Implants - Indication WideningPDF
K2534932026-03-04Dentis Co., Ltd.Dentis SQ-SL AXEL FixturePDF
K2521972026-02-18Nobel Biocare ABNobel Biocare S Series ImplantsPDF
K2522862026-02-02Chengdu Besmile Medical Technology Co.BIORES Dental Implant SystemPDF
K2525852026-01-08Izenimplant Co., Ltd.ZENEX Implant System_R-SystemPDF
K2521452025-12-23Paragon Implant Mfg., LLCGEN5™ and GEN5+™ 3.3mmD Dental ImplantsPDF
K2504762025-12-23Paragon Implant Mfg., LLCNizPlant Dental Implant SystemPDF
K2516052025-12-22DIMPLO, Ltd.DIMPLO Implant SystemPDF
K2520902025-12-12JJGC Indústria e Comércio de MateriaisPterygoid Indication for GM Helix ImplantsPDF
K2511292025-11-07S.I.N. Implant System LtdaS.I.N. Tapered Pro Conical Zygoma Implant SystemPDF
K2519382025-10-30Paragon Implant Mfg., LLCGEN5 and GEN5+ Dental Implant SystemPDF
K2430782025-10-10Osseofuse International, Inc.HexaPLUS S OneDrill Implant SystemPDF
K2439832025-09-29Paltop Advanced Dental Solutions, Ltd.Paltop Dental Implant SystemPDF
K2512622025-09-26S.I.N. Implant System LtdaS.I.N. Dental Implant SystemPDF
K2511482025-09-25Jdentalcare SrlJDEvolution Plus L and JDEvolution Plus LEPDF
K2438342025-08-25Nobel Biocare ABNobelZygoma TiUltra Implant systemPDF
K2516472025-08-21Dentsply Sirona, Inc.MIS C1 Implant System, MIS Seven Implant System, MISPDF
K2502712025-08-18JJGC Indústria e Comércio de MateriaisNeodent Implant System - Zirconia Implant SystemPDF
K2510462025-08-13S.I.N. Implant System LtdaS.I.N. Dental Implant SystemPDF
K2502942025-08-12Institut Straumann AGStraumann® RidgeFit ImplantsPDF
K2512972025-07-24Dentsply Sirona, Inc.MIS LYNX Conical Connection Implant SystemPDF
K2502802025-07-23Arum Dentistry Co., Ltd.SD TL Implant SystemPDF
K2512802025-07-23Terrats Medical SLDESS® Dental ImplantsPDF
K2437312025-07-09P&A USAHEXIM Implant; Samwon General AbutmentsPDF
K2432552025-07-03Truabutment, Inc.URIS Long Implant & AbutmentsPDF
K2516602025-06-27Biomet 3i, LLCT3 Pro Implants– ZimVie Packaging SystemPDF
K2508722025-06-18Bioline Dental Implant Systems, Ltd.Bioline Dental Implant SystemPDF
K2430022025-06-06MBA Biotech Co., Ltd.MBA Biotech Implant SystemPDF
K2420722025-05-14Ceraroot SLCeraRoot TL Implant System (TL)PDF
K2332712025-05-08Synoross Dba OsseoneOsseOne Dental Implant SystemFDA
K2501762025-04-21D.A.N.D. Metal Industries North, Ltd.DAND Dental Implant SystemPDF
K2417032025-02-24Arum Dentistry Co., Ltd.SD Implant SystemFDA
K2414622025-02-11Noris Medical , Ltd.LONGY Implant and LONGY-N ImplantPDF
K2422172025-01-29Surcam Medical Devices and DevelopmentSurcam Dental Implant SystemPDF
K2426612025-01-08Tri Dental Implants Int. AGTRI-matrix® X-Force ImplantsPDF
K2427532025-01-06Arum Dentistry Co., Ltd.SD TL Implant SystemPDF
K2411272024-12-27Cowellmedi Co., Ltd.INNO SLA Mini Plus® Implant SystemPDF
K2419722024-12-27Megagen Implant Co., Ltd.BLUEDIAMOND IMPLANTPDF
K2404352024-12-20Alpha Dent Implants GmbHAlpha Dent Implants Dental Implants SystemPDF
K2430942024-12-19Quickdent Devices Private , Ltd.Quickdent Dental Implant SystemPDF
K2430662024-12-16Ditron Dental, Ltd.Dental Implants and AbutmentsPDF
K2413912024-12-10Institut Straumann AGStraumann® PURE Ceramic ImplantsPDF
K2416922024-11-25Dentsply Sirona, Inc.MIS LYNX Conical Connection Implant SystemPDF
K2330812024-11-15Infinitum Eta, Ltd.NUVENTUS NV.C™ Dental Implant SystemPDF
K2423792024-11-07Ossvis Co., Ltd.LL Implant SystemPDF
K2422612024-11-06Biotech Dental, LLCAccelx Implant SystemPDF
K2403832024-10-31Highness Co., Ltd.Highness Implant SystemPDF
K2405602024-10-30Izenimplant Co., Ltd.ZENEX Implant System_LongFDA
K2417532024-10-23Biomet 3i, LLCImmediate Molar ImplantsPDF
K2401432024-10-11Jdentalcare SrlJDZygoma dental implantsPDF
K2402622024-10-10B.T.I. Biotechnology Institute, Sl.BTI Interna 3.0 Dental Implant System UnicCa®PDF
K2409772024-09-13DenqDenQ Sub SLA Implant SystemPDF
K2402322024-09-13Hiossen, Inc.EK D3.3 and Ultra Wide ImplantsFDA
K2408032024-09-12Surgikor, LLCSurgikor Fixation One, Abutment Blanks and AbutmentsPDF
K2315662024-09-05Medentis Medical GmbHICX-Implant SystemPDF
K2311002024-08-23Proimtech Saglik Urunleri Anonim SirkeProimtech Dental Body Implant, Proimtech Abutment, PPDF
K2338962024-08-16Jdentalcare SrlJDentalCare Dental Implant System: JDEvolution; JDEvFDA
K2408372024-08-15Rdj Tov Implant, Ltd.TOV Dental Implant SystemPDF
K2338082024-07-31Ossvis Co., Ltd.LW Narrow Implant SystemFDA
K2406092024-07-17S.I.N. - Sistema DE Implante Nacional S.I.N. Dental Implant SystemPDF
K2409662024-07-09Keystone Dental, Inc.Prima Plus Conical Implant SystemPDF
K2402022024-06-06Noris Medical , Ltd.Conical Platform Dental Implants SystemPDF
K2401872024-06-05BioHorizons Implant Systems, Inc.Tapered Pro Conical Implant SystemFDA
K2328212024-05-31S.I.N. - Sistema DE Implante Nacional S.I.N. Dental Implant SystemPDF
K2314262024-05-24Hoowon Edi Co., Ltd.8plant Implant SystemPDF
K2327402024-05-22Paltop Advanced Dental Solutions, Ltd.Paltop Short ImplantsPDF
K2405112024-05-20Dentis Co., Ltd.Dentis s-Clean SQ-SL FixturePDF
K2331372024-05-16Mozograu S.A.Ticare Dental Implant SystemsPDF
K2332312024-04-30Ditron Dental, Ltd.Dental Implants and AbutmentsPDF
K2400912024-04-26Arum Dentistry Co., Ltd.NB Mini Implant SystemPDF
K2218472024-04-11Newton Implant Systems, Inc.Ni2 Implant SystemPDF
K2327262024-04-01Southern Implants (Pty), Ltd.External Hex Implant SystemPDF
K2320492024-03-28Neobiotech Co., Ltd.IS-III active Short ImplantPDF
K2322682024-03-25Zeros Co., Ltd.STERI-OSS Implant SystemPDF
K2340492024-03-20Institut Straumann AGStraumann® BLC and TLC Implants - Line extensionPDF
K2218662024-01-18Newton Implant Systems, Inc.S-Plant Dental Implant SystemPDF
K2237142023-12-29Adin Dental Implant Systems , Ltd.UniFit Dental Implant SystemPDF
K2304382023-12-29Truabutment, Inc.URIS Smart Path Implant System & ProstheticPDF
K2331632023-12-19Izenimplant Co., Ltd.ZENEX Implant System_ShortPDF
K2314292023-12-18Idis Co., Ltd.S-Plant Dental Implant SystemPDF
K2319672023-12-07Megagen Implant Co., Ltd.ARi ExCon Implant SystemPDF
K2311272023-12-07S.I.N. - Sistema DE Implante Nacional S.I.N. Dental Implant SystemPDF
K2324182023-12-01Southern Implants (Pty), Ltd.Single Platform SP1 Implant SystemPDF
K2320992023-10-31JJGC Indústria e Comércio de MateriaisNeodent Implant System - GM Zygomatic Implant SystemPDF
K2213152023-10-25Unidental Co., Ltd.UNIdental Symphony Implant SystemPDF
K2313952023-10-18Cowellmedi Co., Ltd.INNO SLA Submerged Narrow Implant SystemPDF
K2301042023-10-16AnthogyrAnthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit PDF
K2236972023-10-13BioHorizons Implant Systems, Inc.MRI compatibility for existing BioHorizons dental im
K2306182023-10-11Megagen Implant Co., Ltd.MegaGen Dental Implant Systems Portfolio - MR Condit
K2302422023-10-05OsteoCentric TechnologiesOsteoCentric Dental Implant SystemFDA
K2227782023-09-23Osstem Implant Co., Ltd.Osstem Implant SystemFDA
K2301082023-09-14Institut Straumann AGStraumann® BLC and TLC ImplantsPDF

87 summaries are archived here for direct download.

Official FDA classification page: DZE
Classification and pathway per current FDA publications. Data from openFDA (CC0).