Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003781339

FEI Number

3003781339

Entity Name

Cybermed Inc.

City/State/Country

Daejeon, KR

Establishment Address

6-26, Yuseong-daero 1205beon-gil, Yuseong-gu, Daejeon 34104, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Cybermed Inc. (Owner Number: 9048516)

Owner / Operator Contact Address

6-26, Yuseong-daero 1205beon-gil, Yuseong-gu, Daejeon, KR-NOTA 34104, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K113543

PMA Number

N/A

All Registered Proprietary Names

REBORN ImplantSystem CORE1 Implant System LUCION; VIMPLANT Accurex HAS Scan Body Carrier 1.2 Hex Driver Wrench Condenser C Sleeve CORE Implant Mount Bone Pusher CORE Mount Driver 1.2 Angled Driver 1.25 Hex Driver Base Metal Carrier CORE Master KIT Simple CORE Master KIT (Short) CORE1 Implant Mount Extension Bone Profiler Crestal Stopper 1.25 Angled Driver CORE Sinus KIT Bone Flatter Template Anchor Depth Gauge & Sinus Curette CORE1 Guide KIT Simple curette2 O Sleeve CORE Mount Extension Bone Packer Bone Carrier Reborn Universal Guide KIT Drill Handle F.A Driver Drill Extension Reborn Sinus Master KIT Depth Gauge & Probe Scan Body 0.9 Hex Driver Turning Handle Universal Ti Cylinder Reborn Prosthetic KIT Scan Body Carrier Guide Holder Implant Driver Digital Lab Analog Drill Guide Universal Impression Cap (Pick-up) Driver Extension Fixture Driver Anchor Sleeve Reborn Guide KIT Lab Analog Anchor Pin Unigrip Driver Universal Healing Cap CORE Sinus Master KIT Pick-up impression coping 0.5 Slot Driver Membrane Lifter Funnel CORE Master KIT (Mini & Short) Hydro Membrane Lifter Universal Temporary Cylinder Tissue Punch Transfer impression coping guide pin Universal Outer Driver CORE1 Implant Mount Membrane Separator CORE Universal Remover and Prosthetic KIT Torque Wrench CORE1 Prosthetic KIT Hydro Membrane Lifter Tube Parallel Pin Universal Plastic Carrier Reborn Master KIT Osteoplasty Bur Fixing Anchor Reborn Master KIT Full ER Tool Path Pin CORE1 Mount Driver CORE Master KIT Scan Body Carrier Screw Flat Tip Driver Probe Transfer impression coping HAS Scan Body CORE Universal Guide KIT Scan Cap curette1 Lateral Wall Expander Universal Metal Carrier Reborn Sinus KIT Solid Lab Analog CORE1 Guide KIT CORE Master KIT (Mini) Pick-up impression coping guide pin Fixture Remover Screw Universal Impression Cap (Transfer) SCS Driver Abutment Screw Driver CORE Master KIT Full Depth Gauge Handpiece Condenser Drill Stopper Universal Lab Analog Scan Body Screw Wrench - Long Stopper Impression cap Ratchet Extension CS Drill CORE Master KIT (Mini) Connecter-handpiece CORE Master KIT (Mini & Short) CORE Z Guide KIT CORE Sinus KIT CORE Sinus Master KIT CORE Master KIT T.A Drill Lateral Drill Remover Drill CORE Universal Guide KIT LS Diamond Bur CORE Master KIT Full CORE Master KIT Simple Bone Profiler Reborn Master KIT Full Lateral Guide Drill Initial Drill Connector-Rachet In2Guide Surgical Template Bone Flatter Reborn Sinus Master KIT CORE1 Guide KIT Simple Tap Drill ABT. Profiler In2Guide Universal Kit Point Drill Reborn Guide KIT First Drill Initial Guide Drill Anchor Drill Crestal Guide Drill Guided Drill Guide Drill CORE D Guide KIT CORE1 Guide KIT Mount(AOS) Reborn Master KIT Reverse Drill Cortical Drill CORE Drill Reborn Universal Guide KIT CORE Universal Remover and Prosthetic KIT LS Carbide Bur CORE Master KIT (Short) Osteoplasty Bur CS First Drill Reborn Sinus KIT Ondemand3DG2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2022-01-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-01-17
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2002-02-07
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2012-10-26
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2018-12-26
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2009-12-01
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2012-10-26

Official Correspondent

KIM CHEOL YOUNG

US Agent Details

April Lee Business: Withus Group Inc. Email: withus6664@gmail.com Phone: (909) 2749971

Related Public Records

Same Entity

Cybermed Inc.

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
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
K903999	O Co., Inc.	OBUTMENT HB	1992-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0029-05	Implant Innovations, Inc.	2	EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003781339. Last updated year: 2026. Please use registration number 3003781339 when referencing this establishment in official correspondence.