Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013584861

FEI Number

3013584861

Entity Name

MEDICLUS CO., LTD

City/State/Country

Cheongju-si Chungbuk, KR

Establishment Address

No. 1210, 134 Gongdan-ro, Heungdeok-gu, Cheongju-si Chungbuk 28576, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Mediclus Co., Ltd (Owner Number: 10053816)

Owner / Operator Contact Address

No. 1210, 134 Gongdan-ro, Heungdeok-gu, Cheongju-si, KR-43 28576, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242713

PMA Number

N/A

All Registered Proprietary Names

Hi-Bond Universal W-Gel Premium Desens Bio-Care One-Stop Any-Print SG Ezi-Sep LC-Resin Ezi-Crown Block Out Resin Dual Once-Fil Flow BLSEAL Putty One-Fil Putty Any-Core Any-Etch Ezi-Stick plus Ezi-Stick Dentto-Dam One-Fil BLSEAL CanalPro CalciSeal One-Fil Putty Injectable Any-Com MD-Solution Endo@Prep EDTA Gel Endo@Prep EDTA Cream Disposable Tip Any-Temp Eugenol Any-Com Flow Any-Paste Any-Com Bulk

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2023-05-23
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2023-05-23
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2023-05-23
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2025-05-02
MVL	Cord, Retraction	Unknown	Class U	N/A	2026-03-09
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2021-11-24
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2018-09-27
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2025-03-17
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-12-20
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2026-05-18
EKI	Carrier, Amalgam, Operative	Dental	Class 1	872.4565	2023-05-08
EIE	Dam, Rubber	Dental	Class 1	872.6300	2017-01-13
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2024-01-29
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2025-08-25
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-09-28
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2023-01-17
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2026-06-01
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	2023-12-21
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-04-16
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2026-01-13
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-02-10

Official Correspondent

Kyoung-Eun Kim

US Agent Details

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

Related Public Records

Same Entity

Mediclus 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
K033295	Novamin Technology, Inc.	BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN	2003-10-28
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013584861. Last updated year: 2026. Please use registration number 3013584861 when referencing this establishment in official correspondence.