Medical Device Manufacturer · KR , Yuseong-Gu, Daejeon

Arum Dentistry Co., Ltd.

17 submissions · 17 cleared · Since 2020
17
Total
17
Cleared
0
Denied

Arum Dentistry Co., Ltd. — FDA 510(k) Submissions

Arum Dentistry Co., Ltd. has submitted 17 FDA 510(k) premarket notifications since 2020, of which 17 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, Powder, Porcelain, Crown And Bridge, Temporary, Resin, Material, Tooth Shade, Resin . Use the specialty filter in the sidebar to narrow results.

17 devices
1–17 of 17
SD TL Implant System
K250280 · DZE Implant, Endosseous,... · Dental
Jul 2025 173d
ARENA Star, Galaxy Star
K250063 · EIH Powder, Porcelain · Dental
Jul 2025 181d
SD Implant System
K241703 · DZE Implant, Endosseous,... · Dental
Feb 2025 256d
SD TL Implant System
K242753 · DZE Implant, Endosseous,... · Dental
Jan 2025 116d
Customized Abutment
K242245 · NHA Abutment, Implant,... · Dental
Nov 2024 117d
C&B NFH Hybrid
K232559 · EBF Material, Tooth Shade, Resin · Dental
Sep 2024 385d
Ti-Base & Master Fix
K240603 · NHA Abutment, Implant,... · Dental
Jun 2024 93d
Customized Abutment
K234112 · NHA Abutment, Implant,... · Dental
May 2024 134d
NB Mini Implant System
K240091 · DZE Implant, Endosseous,... · Dental
Apr 2024 105d
Angled Abutment
K232560 · NHA Abutment, Implant,... · Dental
Dec 2023 118d
NB Implant System
K230725 · DZE Implant, Endosseous,... · Dental
Jul 2023 107d
Customized Abutment
K223634 · NHA Abutment, Implant,... · Dental
Apr 2023 144d
Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)
K223253 · EIH Powder, Porcelain · Dental
Feb 2023 129d
NB 1 SA Implant System
K222131 · DZE Implant, Endosseous,... · Dental
Sep 2022 63d
NB 1 SA Implant System
K213506 · DZE Implant, Endosseous,... · Dental
Apr 2022 156d
C&B 5.0 Hybrid
K210817 · EBG Crown And Bridge,... · Dental
Dec 2021 265d
Pre-Milled Blank
K193425 · NHA Abutment, Implant,... · Dental
Mar 2020 90d
Filters
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