Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015978392

FEI Number

3015978392

Entity Name

ARUM DENTISTRY Co., Ltd.

City/State/Country

Yuseong-gu Daejeon, KR

Establishment Address

23, Gukjegwahak 11-ro, Yuseong-gu Daejeon 34002, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ARUM DENTISTRY Co., Ltd (Owner Number: 10066396)

Owner / Operator Contact Address

23, Gukjegwahak 11-ro, Yuseong-gu, KR-30 34002, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250063

PMA Number

N/A

All Registered 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 Abutment Screw Pre-milled Blank C&B NFH Hybrid Cover Screw NB I Fixture Healing Abutment Cemented Abutment Multi Digital Cylinder Healing Abutment SD Bone Level Fixture Multi Ti Cylinder 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 Healing Abutment Scan Healing Abutment Abutment Screw Cover Screw Cemented Abutment Mini Scan Healing Abutment Screw Angled Abutment Mini C&B 5 Hybrid Pre-milled Blank Abutment Screw Multi Pre-Milled Cylinder SD Tissue Level Fixture Scan Healing Abutment Screw NB II Fixture Scan Healing Abutment ARENA Star Galaxy Star

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-03-04
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2025-03-04
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-11-26
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-09-20
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2024-09-20
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-09-27
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-09-27
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2025-07-24
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-24
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2021-04-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2024-04-28
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-04-28
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2021-12-27
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-04-01
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2025-01-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-01-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-07-02
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-07-02
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2025-07-13

Official Correspondent

Jeonghyun Lee

US Agent Details

Hyung Jin Kim Business: Arum Dentistry USA INC Email: arum_ra@arumdentistry.com Phone: (949) 2279568

Related Public Records

Same Entity

ARUM DENTISTRY Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015978392. Last updated year: 2026. Please use registration number 3015978392 when referencing this establishment in official correspondence.