Medical Device Manufacturer · KR , Busan

Osstem Implant Co., Ltd.

68 submissions · 68 cleared · Since 2006
68
Total
68
Cleared
0
Denied

Osstem Implant Co., Ltd. — FDA 510(k) Submissions

Osstem Implant Co., Ltd. has submitted 68 FDA 510(k) premarket notifications since 2006, of which 68 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Implant, Endosseous, Root-form, Abutment, Implant, Dental, Endosseous, Material, Impression, Plate, Bone, Unit, X-ray, Extraoral With Timer . Use the specialty filter in the sidebar to narrow results.

68 devices
1–25 of 68
Healing Abutment System
K251434 · NHA Abutment, Implant,... · Dental
Mar 2026 300d
Bone Screw
K251569 · DZL Screw, Fixation,... · Dental
Aug 2025 83d
Estar-ZE
K242521 · EIH Powder, Porcelain · Dental
Nov 2024 89d
T2 Plus
K233806 · OAS X-ray, Tomography,... · Radiology
Sep 2024 282d
TS Abutment System
K233194 · NHA Abutment, Implant,... · Dental
Feb 2024 145d
SS Abutment System
K232220 · NHA Abutment, Implant,... · Dental
Dec 2023 132d
N1
K232012 · EHD Unit, X-ray, Extraoral... · Radiology
Nov 2023 145d
Osstem Implant System
K222778 · DZE Implant, Endosseous,... · Dental
Sep 2023 374d
Osstem Abutment System
K221684 · NHA Abutment, Implant,... · Dental
Sep 2022 90d
T2
K212303 · OAS X-ray, Tomography,... · Radiology
Sep 2021 60d
Estar-Z
K210097 · EIH Powder, Porcelain · Dental
Jul 2021 169d
HySil Plus Impression Materials
K210041 · ELW Material, Impression · Dental
Mar 2021 70d
HySil Super Fast Impression Materials
K192941 · ELW Material, Impression · Dental
Jan 2020 104d
K3
K183347 · EIA Unit, Operative Dental · Dental
Sep 2019 275d
T1-CS, T1-C
K183475 · OAS X-ray, Tomography,... · Radiology
Aug 2019 256d
Bone Screw, Bone Tack
K182881 · DZL Screw, Fixation,... · Dental
Aug 2019 298d
Osstem Abutment System
K182091 · NHA Abutment, Implant,... · Dental
Jul 2019 343d
OssBuilder System
K181854 · DZL Screw, Fixation,... · Dental
May 2019 300d
HySil Impression Materials
K181236 · ELW Material, Impression · Dental
Sep 2018 126d
OssBuilder System
K172354 · JEY Plate, Bone · Dental
Mar 2018 235d
HySil Impression Materials
K170736 · ELW Material, Impression · Dental
Jun 2017 89d
OSSTEM Implant System - Abutment
K161689 · NHA Abutment, Implant,... · Dental
May 2017 336d
SS SA Fixture
K163557 · DZE Implant, Endosseous,... · Dental
May 2017 147d
ET US SS Prosthetic system
K160670 · NHA Abutment, Implant,... · Dental
Apr 2017 411d
TSIII BA Fixture
K163088 · DZE Implant, Endosseous,... · Dental
Apr 2017 168d
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