Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012564447

FEI Number

3012564447

Entity Name

HUMEDITECH CO., LTD

City/State/Country

Gimhae-si Gyeongnam, KR

Establishment Address

26, Yeocha-ro, Saengnim-myeon, Gimhae-si Gyeongnam 50801, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HUMEDITECH Co., Ltd (Owner Number: 10091775)

Owner / Operator Contact Address

26, Yeocha-ro, Saengnim-myeon, Gimhae-si, KR-48 50801, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Drill Extension Initial Drill Sun-Bone Packer Three Cutter Twist Drill Plastic Cap Twist Drill TG KIT_Guide Fixture Driver, Bone Profiler, Vertical Anchor Screw, Drill Guide, Mount Driver, Hand Driver UG KIT_Guide Point Drill, Guide Initial Drill, Guide Straight Drill, Guide Tissue Punch, Bone Profiler TG KIT_Lateral Anchor Drill, Lateral Anchor Driver, Lateral Anchor Screw, Torque Wrench UG KIT_Drill Guide, Lateral Anchor Drill, Lateral Anchor Driver, Lateral Anchor Screw, Torque Wrench NRG KIT_Guide Tissue Punch, Drill Guide, Guide Fixture Driver, Drill Extension PNUADD Taper Surgical KIT_Taper Cortical Drill, Parallel Pin, Hand Driver, Ratchet Driver, No Mount Driver NRG KIT_Guide Taper Drill, Guide Point Drill, Guide Initial Drill PNUADD Taper Surgical KIT_Fixture Driver, Depth Gauge, Torque Ratchet C-Bone Packer SG KIT_Guide Initial Drill, Guide Taper Drill, Guide Point Drill, Guide Tissue Punch 1.2 Hex. Driver Long and Short Torque Extension G-Packer SG KIT_Lateral Anchor Screw, Vertical Anchor Screw, Torque Wrench, Drill Guide, Guide Counter Sink NoMount Driver Long and Short Parallel Pin Taper Drill TG KIT_Guide Point Drill, Guide Initial Drill, Guide Step Drill, Guide Taper Drill, Guide Tissue Punch PNUADD Taper Surgical KIT_Lance Drill, Lindemann Drill, Drill Extension, Straight Drill, Taper Surgical Drill Tissue Punch Kimplant KIT case Fixture Driver Long and Short Lance Drill Taper Cortical Drill Torque Wrench Kimplant KIT SG KIT_Fixture Driver, Hand Driver, Mount Driver, Lateral Anchor Drill, Lateral Anchor Driver G-Remover

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2024-10-31

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

HUMEDITECH Co., Ltd

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

View Entity Profile →

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

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3042200066	HUB BIOTECH CO., LTD.	BUCHEON-SI Gyeonggi, KR
3042852773	COVISION CO., LTD.	Incheon, KR
3009847764	GMI DENTAL IMPLANTOLOGY, S.L.	Lleida Lerida, ES

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012564447. Last updated year: 2026. Please use registration number 3012564447 when referencing this establishment in official correspondence.