FDA Registration
Active
🇰🇷 South Korea
ARUM DENTISTRY Co., Ltd.
Reg #: 3015978392
·
FEI: 3015978392
·
Expires 2026
Products
7
Proprietary Names
155
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- ARUM DENTISTRY Co., Ltd.
- Registration Number
- 3015978392
- FEI Number
- 3015978392
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 23, Gukjegwahak 11-ro
- City
- Yuseong-gu Daejeon
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K241703
Owner / Operator
- Firm Name
- ARUM DENTISTRY Co., Ltd
- Operator Number
- 10066396
- Address
- 23, Gukjegwahak 11-ro
- City
- Yuseong-gu
- State
- Daejeon
- Postal Code
- 34002
- Country
- KR
- Correspondent
- Jeonghyun Lee
US Agent
- Business Name
- Arum Dentistry USA INC
- Contact Name
- Hyung Jin Kim
- Address
- 17952 Sky Park Cir
- City
- Irvine
- State
- CA
- ZIP
- 92614
- Country
- US
- [email protected]
- Phone
- 949 2279568
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2025-03-04 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2025-03-04 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2024-09-20 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2024-09-20 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2021-04-14 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2025-07-13 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2022-12-04 |
Proprietary Names
Multi Scan Healing Cap
Scan Healing Abutment Screw
Multi Temporary Cylinder
Healing Abutment
Cover Screw
Multi Digital Cylinder
SD Bone Level Fixture
Angled Abutment
Multi Angled Abutment
Master Fix
Scan Healing Abutment
Master Fix Screw
Cemented Abutment
Multi Abutment
Temporary Abutment
Multi Master Fix
Multi Master Fix Screw
Multi Ti Cylinder
Digital Abutment
Multi Scan Healing Cap Screw
Abutment Screw
Multi Angled Abutment Screw
Pre-milled Blank
C&B NFH Hybrid
NB I Fixture
Multi Healing Cap
SD Tissue Level Fixture
Multi Angled Cylinder
Lab Screw
Direction pin
Screw Driver
NB ESSENTIAL KIT
Multi Pick-up Impression Coping
Abutment Remover Tool
Screw Driver Ratchet
Pick up Impression Coping Screw
NB MASTER KIT
Guide Fixture Driver Wrench
Screw Hex Remover Tool Guide
F1 Plasma
Solution Kit
Sinus Curette
SD TL Surgical KIT
Torque Ratchet
Tissue Punch
Drill Stopper
Anchor Screw Driver Wrench
Multi Abutment Holder
Multi Transfer Impression Coping Screw
Transfer Impression Coping Screw
Model Scanbody
Bite Impression Coping Screw
Screw Driver Wrench
Scanbody Screw
SG 5
Multi Bite Impression Coping
Remover Tool
Sinus Drill Stopper
Multi Lab Analog
Mount Pin
Trial Pin
Fixture Driver Machine
Fixture Driver Ratchet
SD Surgical KIT
SD Multi Driver Machine
Implant Anchor Body
Parallel Pin
Multi Pick-up Impression Coping Screw
Drill Extension
Intraoral Scanbody Screw
Anchor Screw
Multi Transfer Impression Coping
Screw Hex Remover Tool
Multi Bite Impression Coping Screw
SD Digital KIT
SD BL Surgical KIT
Scanbody
Transfer Impression Coping
Torx Remover Tool
JIG
Torque Extension
NB Digital KIT
Intraoral Scanbody
Machine Driver Connector
Guide Fixture Driver Machine
Multi Scanbody
Lab Analog
Sleeve
Arum Prosthetic KIT
Anchor Screw Driver Machine
SES Bur KIT
Bone Profiler KIT
Crest Remover
Implant Anchor Screw
Fixture Driver Wrench
Digital Prosthetic KIT
Pick up Impression Coping
Mini Digital Kit
SES KIT
Digital Anchor KIT
Screw Remover Tool
TL Holder
Bone Spreader
SES Surgical KIT
Depth Gauge
Screw Driver Hand
Bite Impression Coping
Fixture Remover Screw
Multi Scanbody Screw
Fixture Remover Tool
Master Fix Prosthetic KIT
SD Multi Driver Wrench
Torque Wrench
NB REGULAR KIT
Screw Driver Machine
Implant Anchor
NB Fixture Mini
Cemented Abutment Mini
Angled Abutment Mini
C&B 5 Hybrid
Multi Pre-Milled Cylinder
NB II Fixture
ARENA Star
Galaxy Star
Montblanc
Trione HT
Trione HT+
Arena
Trione C
Sinus Crestal Drill
Simple Drill
Path Drill
Sinus Countersink
Anchor Drill
First Drill
Bone Profiler
Guide Final Drill
Cortical Drill
Final Drill
Guide Initial Drill
Guide Countersink
Pilot Drill
Bone Flattening Drill
Sinus Lateral Drill
Guide Step Drill
Point Drill
Step Drill
Initial Drill
Countersink
Round Bur
Guide Cortical Drill
Arena Star
Twin-Zero
Twin-Zero Screw
Ti-Base
Establishment Types
Manufacture Medical Device