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510(k) K172345

Device
IU Implant System
Applicant
Warantec Co.,Ltd.
510(k) number
K172345
Product code
DZE  
Decision
Substantially Equivalent (SESE)
Decision date
2018-06-18
Date received
2017-08-02
Regulation
872.3640
Classification name
Implant, Endosseous, Root-form
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Dong-Hwa Jang
Address
#411, #412, 474, Dunchon-Daero, Jungwon-Gu Seongnam-Si KR 13229 13229

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DZE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic AB2026-05-12
K252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.2026-03-23
K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.2026-03-16
K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG2026-03-10
K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.2026-03-04
K252197Nobel Biocare S Series ImplantsNobel Biocare AB2026-02-18
K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.2026-02-02
K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.2026-01-08
K252145GEN5™ and GEN5+™ 3.3mmD Dental ImplantsParagon Implant Mfg., LLC2025-12-23
K250476NizPlant Dental Implant SystemParagon Implant Mfg., LLC2025-12-23
K251605DIMPLO Implant SystemDIMPLO, Ltd.2025-12-22
K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.2025-12-12
K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda2025-11-07
K251938GEN5 and GEN5+ Dental Implant SystemParagon Implant Mfg., LLC2025-10-30
K243078HexaPLUS S OneDrill Implant SystemOsseofuse International, Inc.2025-10-10

Legacy Summary#

summary

FDA Review#

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