Atlas FDA

DZE

1,547 FDA 510(k) clearances · Product code

156 daysmedian time to decision
399 days90th percentile
1,547clearances measured

FDA profile

Official device name
Implant, Endosseous, Root-Form
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3640
Medical specialty
Dental
Flags
Implant
Adverse events (MAUDE)
2021: 479,619 · 2022: 483,224 · 2023: 537,585 · 2024: 697,102 · 2025: 745,835 · 2026: 452,119
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
UNIQA® Dental Implants System (K251188)Uniqa Dental, Ltd.2026-06-25
MegaGen Zygoma Dental Implant System (K251232)Megagen Implant Co., Ltd.2026-06-18
Dental Implant System (K250806)A.B. Dental Devices , Ltd.2026-06-18
INOSS System (K260006)Inosys, Inc.2026-06-17
Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant (K252731)Promimic AB2026-05-12
Adin Long Dental Implant System (K252031)Adin Dental Implant Systems , Ltd.2026-03-23
ZENEX Implant System_Short (R-System) (K253334)Izenimplant Co., Ltd.2026-03-16
Straumann® BLC Implants - Indication Widening (K252168)Institut Straumann AG2026-03-10
Dentis SQ-SL AXEL Fixture (K253493)Dentis Co., Ltd.2026-03-04
Nobel Biocare S Series Implants (K252197)Nobel Biocare AB2026-02-18
BIORES Dental Implant System (K252286)Chengdu Besmile Medical Technology Co., Ltd.2026-02-02
ZENEX Implant System_R-System (K252585)Izenimplant Co., Ltd.2026-01-08
GEN5™ and GEN5+™ 3.3mmD Dental Implants (K252145)Paragon Implant Mfg., LLC2025-12-23
NizPlant Dental Implant System (K250476)Paragon Implant Mfg., LLC2025-12-23
DIMPLO Implant System (K251605)DIMPLO, Ltd.2025-12-22
Pterygoid Indication for GM Helix Implants (K252090)JJGC Indústria e Comércio de Materiais Dentários S.A.2025-12-12
S.I.N. Tapered Pro Conical Zygoma Implant System (K251129)S.I.N. Implant System Ltda2025-11-07
GEN5 and GEN5+ Dental Implant System (K251938)Paragon Implant Mfg., LLC2025-10-30
HexaPLUS S OneDrill Implant System (K243078)Osseofuse International, Inc.2025-10-10
Paltop Dental Implant System (K243983)Paltop Advanced Dental Solutions, Ltd.2025-09-29
S.I.N. Dental Implant System (K251262)S.I.N. Implant System Ltda2025-09-26
JDEvolution Plus L and JDEvolution Plus LE (K251148)Jdentalcare Srl2025-09-25
NobelZygoma TiUltra Implant system (K243834)Nobel Biocare AB2025-08-25
MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System (K251647)Dentsply Sirona, Inc.2025-08-21
Neodent Implant System - Zirconia Implant System (K250271)JJGC Indústria e Comércio de Materiais Dentários S.A.2025-08-18
S.I.N. Dental Implant System (K251046)S.I.N. Implant System Ltda2025-08-13
Straumann® RidgeFit Implants (K250294)Institut Straumann AG2025-08-12
MIS LYNX Conical Connection Implant System (K251297)Dentsply Sirona, Inc.2025-07-24
SD TL Implant System (K250280)Arum Dentistry Co., Ltd.2025-07-23
DESS® Dental Implants (K251280)Terrats Medical SL2025-07-23
HEXIM Implant; Samwon General Abutments (K243731)P&A USA2025-07-09
URIS Long Implant & Abutments (K243255)Truabutment, Inc.2025-07-03
T3 Pro Implants– ZimVie Packaging System (K251660)Biomet 3i, LLC2025-06-27
Bioline Dental Implant System (K250872)Bioline Dental Implant Systems, Ltd.2025-06-18
MBA Biotech Implant System (K243002)MBA Biotech Co., Ltd.2025-06-06
CeraRoot TL Implant System (TL) (K242072)Ceraroot SL2025-05-14
OsseOne Dental Implant System (K233271)Synoross Dba Osseone2025-05-08
DAND Dental Implant System (K250176)D.A.N.D. Metal Industries North, Ltd.2025-04-21
SD Implant System (K241703)Arum Dentistry Co., Ltd.2025-02-24
LONGY Implant and LONGY-N Implant (K241462)Noris Medical , Ltd.2025-02-11
Surcam Dental Implant System (K242217)Surcam Medical Devices and Developments, Ltd.2025-01-29
TRI-matrix® X-Force Implants (K242661)Tri Dental Implants Int. AG2025-01-08
SD TL Implant System (K242753)Arum Dentistry Co., Ltd.2025-01-06
INNO SLA Mini Plus® Implant System (K241127)Cowellmedi Co., Ltd.2024-12-27
BLUEDIAMOND IMPLANT (K241972)Megagen Implant Co., Ltd.2024-12-27
Alpha Dent Implants Dental Implants System (K240435)Alpha Dent Implants GmbH2024-12-20
Quickdent Dental Implant System (K243094)Quickdent Devices Private , Ltd.2024-12-19
Dental Implants and Abutments (K243066)Ditron Dental, Ltd.2024-12-16
Straumann® PURE Ceramic Implants (K241391)Institut Straumann AG2024-12-10
MIS LYNX Conical Connection Implant System (K241692)Dentsply Sirona, Inc.2024-11-25
NUVENTUS NV.C™ Dental Implant System (K233081)Infinitum Eta, Ltd.2024-11-15
LL Implant System (K242379)Ossvis Co., Ltd.2024-11-07
Accelx Implant System (K242261)Biotech Dental, LLC2024-11-06
Highness Implant System (K240383)Highness Co., Ltd.2024-10-31
ZENEX Implant System_Long (K240560)Izenimplant Co., Ltd.2024-10-30
Immediate Molar Implants (K241753)Biomet 3i, LLC2024-10-23
JDZygoma dental implants (K240143)Jdentalcare Srl2024-10-11
BTI Interna 3.0 Dental Implant System UnicCa® (K240262)B.T.I. Biotechnology Institute, Sl.2024-10-10
DenQ Sub SLA Implant System (K240977)Denq2024-09-13
EK D3.3 and Ultra Wide Implants (K240232)Hiossen, Inc.2024-09-13
Surgikor Fixation One, Abutment Blanks and Abutments (K240803)Surgikor, LLC2024-09-12
ICX-Implant System (K231566)Medentis Medical GmbH2024-09-05
Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw (K231100)Proimtech Saglik Urunleri Anonim Sirketi2024-08-23
JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus (K233896)Jdentalcare Srl2024-08-16
TOV Dental Implant System (K240837)Rdj Tov Implant, Ltd.2024-08-15
LW Narrow Implant System (K233808)Ossvis Co., Ltd.2024-07-31
S.I.N. Dental Implant System (K240609)S.I.N. - Sistema DE Implante Nacional S.A.2024-07-17
Prima Plus Conical Implant System (K240966)Keystone Dental, Inc.2024-07-09
Conical Platform Dental Implants System (K240202)Noris Medical , Ltd.2024-06-06
Tapered Pro Conical Implant System (K240187)BioHorizons Implant Systems, Inc.2024-06-05
S.I.N. Dental Implant System (K232821)S.I.N. - Sistema DE Implante Nacional S.A.2024-05-31
8plant Implant System (K231426)Hoowon Edi Co., Ltd.2024-05-24
Paltop Short Implants (K232740)Paltop Advanced Dental Solutions, Ltd.2024-05-22
Dentis s-Clean SQ-SL Fixture (K240511)Dentis Co., Ltd.2024-05-20
Ticare Dental Implant Systems (K233137)Mozograu S.A.2024-05-16
Dental Implants and Abutments (K233231)Ditron Dental, Ltd.2024-04-30
NB Mini Implant System (K240091)Arum Dentistry Co., Ltd.2024-04-26
Ni2 Implant System (K221847)Newton Implant Systems, Inc.2024-04-11
External Hex Implant System (K232726)Southern Implants (Pty), Ltd.2024-04-01
IS-III active Short Implant (K232049)Neobiotech Co., Ltd.2024-03-28
STERI-OSS Implant System (K232268)Zeros Co., Ltd.2024-03-25
Straumann® BLC and TLC Implants - Line extension (K234049)Institut Straumann AG2024-03-20
S-Plant Dental Implant System (K221866)Newton Implant Systems, Inc.2024-01-18
URIS Smart Path Implant System & Prosthetic (K230438)Truabutment, Inc.2023-12-29
UniFit Dental Implant System (K223714)Adin Dental Implant Systems , Ltd.2023-12-29
ZENEX Implant System_Short (K233163)Izenimplant Co., Ltd.2023-12-19
S-Plant Dental Implant System (K231429)Idis Co., Ltd.2023-12-18
ARi ExCon Implant System (K231967)Megagen Implant Co., Ltd.2023-12-07
S.I.N. Dental Implant System (K231127)S.I.N. - Sistema DE Implante Nacional S.A.2023-12-07
Single Platform SP1 Implant System (K232418)Southern Implants (Pty), Ltd.2023-12-01
Neodent Implant System - GM Zygomatic Implant System (K232099)JJGC Indústria e Comércio de Materiais Dentários S.A.2023-10-31
UNIdental Symphony Implant System (K221315)Unidental Co., Ltd.2023-10-25
INNO SLA Submerged Narrow Implant System (K231395)Cowellmedi Co., Ltd.2023-10-18
Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL (K230104)Anthogyr2023-10-16
MRI compatibility for existing BioHorizons dental implants and abutments (K223697)BioHorizons Implant Systems, Inc.2023-10-13
MegaGen Dental Implant Systems Portfolio - MR Conditional (K230618)Megagen Implant Co., Ltd.2023-10-11
OsteoCentric Dental Implant System (K230242)OsteoCentric Technologies2023-10-05
Osstem Implant System (K222778)Osstem Implant Co., Ltd.2023-09-23
Straumann® BLC and TLC Implants (K230108)Institut Straumann AG2023-09-14
Oneday Mini Implant System (K222946)Oneday Biotech Co., Ltd.2023-08-23
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Every clearance here is in the API, with alerts when new ones post.