Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007649394

FEI Number

3007649394

Entity Name

MEDIMECCA CO LTD

City/State/Country

Seoul, KR

Establishment Address

104, 105, 109, 110, Daeryung Techno Town 3, 115, Gasan digital 2-ro, Geumcheon-gu, Seoul 08505, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEDIMECCA CO LTD (Owner Number: 10029396)

Owner / Operator Contact Address

104, 105, 109, 110, Daeryung Techno Town 3, 115, Gasan digital 2-ro, Geumcheon-gu, Seoul, KR-NOTA 08505, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CHAORUM Implant System M+ Implant System Biothread Dental Implant System Honor'st Implant DISOAR Implant System DG00 DSR (Disk-up Sinus Reamer) CHAORUM Implant System Biothread Dental Implant Systems UD Implant System M+ Implant System Honor'st Implant DG00 Guide (Point) Drill Taper Drill PILOT DRILL Twist Drill Sidecut (Lindemann) Drill Sinus+Cortical Drill STOPPER Cortical Drill TAP DRILL DSR (Disk-up Sinus Reamer) TD6013 TD4008 TD6011 TD6008 TD4011 TD2013 TD3513 TD4511 TD4513 TD5008 TD2011 TD6007 TD5010 HTD500 HTD450 HTD400 TD2007 HTD600 TD4510 TD3508 TD5013 TD4508 TD5011 HTD350 TD5007 TD4007 TD2008 TD6010 TD4010 TD2010 PGD20 SCD20 TD4013 TD3511 TD4507 TD3510 Ph dental Honorst Implant System CHAORUM Implant System - Hex Hand & Ratchet Driver (Various Models) CHAORUM Implant System - Drill Extention (Various Models) CHAORUM Implant System - Impression Coping (Various Models) CHAORUM Implant System - Hand Piece Fixture Driver (Various Models) CHAORUM Implant System - Tab Drill (Various Models) CHAORUM Implant System - Side Cut Drill (Various Models) CHAORUM Implant System - Plastic UCLA Abutment (Various Models) CHAORUM Implant System -Hex Handpiece Driver (Various Models) UD Implant System - Impression Coping (Various Models) CHAORUM Implant System - Fixture Drvier Adapter (Various Models) CHAORUM Implant System - Ball Abutment Driver (Various Models) CHAORUM Implant System - Lab Analog (Various Models) CHAORUM Implant System - Depth Gauge (Various Models) CHAORUM Implant System - Impression Coping Screw (Various Models) CHAORUM Implant System - Ball Abutment Driver O-ring (Various Models) UD Implant System - Drill Extention (Various Models) CHAORUM Implant System - Drill Stopper (Various Models) UD Implant System - Hex Hand & Ratchet Driver (Various Models) CIS-T KIT CHAORUM Implant System - Point Drill (Various Models) CHAORUM Implant System - Torque Wrench Fixture Driver (Various Models) UD Implant System - Drill Stopper (Various Models) UDISFK UD Implant System - Lab Analog (Various Models) CHAORUM Implant System - Parallel Pin (Various Models) UD Implant System - Depth Gauge (Various Models) UD Implant System - Twist Drill (Various Models) UD Implant System - Hand Piece Fixture Driver (Various Models) CHAORUM Implant System - Fixture Direction Pin (Various Models) UD Implant System - Impression Coping Screw (Various Models) UD Implant System - Torque Wrench (Various Models) UD Implant System - Ball Abutment Driver (Various Models) CHAORUM Implant System - Torque Wrench (Various Models) CHAORUM Implant System - SUGICAL KIT TRAY (various models) CHAORUM Implant System - Twist Drill (Various Models) UD Implant System - Point Drill (Various Models) CHAORUM Implant System - Hand piece driver (various models) CHAORUM Implant System - Submerged Impression Coping Transfer (various models) CHAORUM Implant System - SUB PROTECTIVE CAP (various models) CHAORUM Implant System - Drill (various models) CHAORUM Implant System - Twist Drill Stopper (various models) CHAORUM Implant System - Submerged Plastic UCLA (various models) UD Implant System - Hex Handpiece Driver (Various Models) UD Implant System - Tab Drill (Various Models) UD Implant System - Fixture Driver Adapter (Various Models) CHAORUM Implant System - Handpiece Driver Tip (various models) CHAORUM Implant System - Trepan Drill (various models) UD Implant System - Side Cut Drill (Various Models) CIS-TS UD Implant System - Torque Wrench Fixture Driver (Various Models) UD Implant System - Ball Abutment Driver O-ring (Various Models) HD120(Tool) CHAORUM Implant System - Pilot Drill (various models) UD Implant System - Parallel Pin (Various Models) UD Implant System - Fixture Direction Pin (Various Models) CHAORUM Implant System - Handpiece Drill Tip (various models) CHAORUM Implant System - PT Tray (various models) CHAORUM Implant System - AT Tray (various models) CHAORUM Implant System - Oring Abutment Driver (various models) CHAORUM Implant System - Handle (various models) CHAORUM Implant System - Tap Drill (various models) CHAORUM Implant System - Submerged Impression Coping Pick-up (various models) CHAORUM Implant System - Driver Shaft (various models) EZ Guide KIT CHAORUM Full KIT HONORST Full KIT Onebody KIT Arman SEMI KIT CHAORUM SEMI KIT Onebody Implant Kit 1 T1 Taper Kit Custom Kit T1 Taper Guide Kit EZ Guide Kit 1

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	2017-02-07
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-02-07
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2009-05-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2014-02-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2014-02-19
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2013-03-25
EJL	Bur, Dental	Dental	Class 1	872.3240	2013-02-07
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2020-09-25
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-09-25
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2013-02-07

Official Correspondent

Young Hyun Han

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 9225276

Related Public Records

Same Entity

MEDIMECCA 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
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 3007649394. Last updated year: 2026. Please use registration number 3007649394 when referencing this establishment in official correspondence.