FDA.reportPublic FDA data

510(k) K231395

Device
INNO SLA Submerged Narrow Implant System
Applicant
Cowellmedi Co., Ltd.
510(k) number
K231395
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-18
Date received
2023-05-15
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
Haejun Lee
Address
48, Hakgam-Daero 221beon-Gil, Sasang-Gu Busan KR 46986 46986

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
K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.2026-06-25
K250806Dental Implant SystemA.B. Dental Devices , Ltd.2026-06-18
K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.2026-06-18
K260006INOSS SystemInosys, Inc.2026-06-17
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
K250476NizPlant Dental Implant SystemParagon Implant Mfg., LLC2025-12-23
K252145GEN5™ and GEN5+™ 3.3mmD Dental ImplantsParagon Implant Mfg., LLC2025-12-23
K251605DIMPLO Implant SystemDIMPLO, Ltd.2025-12-22