Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018070878

FEI Number

3018070878

Entity Name

MK MEDITECH

City/State/Country

Seongnam-si Gyeonggi, KR

Establishment Address

Room # 511, 54, Changeop-ro, Sujeong-gu, Seongnam-si Gyeonggi 13449, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MK Meditech (Owner Number: 10080664)

Owner / Operator Contact Address

Room # 511, 54, Changeop-ro, Sujeong-gu, Seongnam-si, KR-41 13449, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210559

PMA Number

N/A

All Registered Proprietary Names

MK Drill Bit ATOZ Screwdriver ATOZ Utility Wire ATOZ Expander, ATOZ Key, Model ATOZ, Guide ATOZ ATOZ Mini-Screw

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QRQ	Non-Irrigation Endosseous Dental Implant Drill Bits	Dental	Class 1	872.3980	2022-04-26
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2021-12-20
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2021-12-20
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2021-02-18
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2021-12-20

Official Correspondent

Minsu Kim

US Agent Details

Ki Beom Kim Email: kkim8@slu.edu Phone: (314) 9778367

Related Public Records

Same Entity

MK Meditech

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
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16
K110392	Psm Medical Solutions	PSM LOMAS / BENEFIT SCREWS	2011-12-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

Similar Registrations

Registration Number	Establishment Name	Location
3030039110	DMI TECHNOLOGY LLC	Lynbrook, NY, US
3005497913	MICRO PRECISION SWISS	Santa Ana, CA, US
9611993	NOBEL BIOCARE AB, PRODUKTION	KARLSKOGA Orebro, SE
3005409899	PARAGON IMPLANT MFG., LLC	Calabasas, CA, US
3017013344	GLOBAL DENTAL TRANSFER LTD	Beer Sheva Southern, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018070878. Last updated year: 2026. Please use registration number 3018070878 when referencing this establishment in official correspondence.