FDA Registration
Active
🇰🇷 South Korea
MEDICLUS CO., LTD
Reg #: 3013584861
·
FEI: 3013584861
·
Expires 2026
Products
14
Proprietary Names
31
Establishment Types
1
Classifications
14
Registration Details
- Registration Name
- MEDICLUS CO., LTD
- Registration Number
- 3013584861
- FEI Number
- 3013584861
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 1210, 134 Gongdan-ro, Heungdeok-gu
- City
- Cheongju-si Chungbuk
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K230465
Owner / Operator
- Firm Name
- Mediclus Co., Ltd
- Operator Number
- 10053816
- Address
- No. 1210, 134 Gongdan-ro, Heungdeok-gu
- City
- Cheongju-si
- State
- Chungbuk
- Postal Code
- 28576
- Country
- KR
- Correspondent
- Kyoung-Eun Kim
US Agent
- Business Name
- LK Consulting Group USA, Inc.
- Contact Name
- Priscilla Chung
- Address
- 2552 Walnut Ave Ste 230
- City
- Tustin
- State
- CA
- ZIP
- 92780
- Country
- US
- [email protected]
- Phone
- 714 9225276
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2023-05-23 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2023-05-23 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2023-05-23 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2025-05-02 |
| Cord, Retraction | MVL | Class U | Unknown | No | 2026-03-09 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2021-11-24 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2018-09-27 |
| Resin, Root Canal Filling | KIF | Class 2 | Dental | No | 2025-03-17 |
| Carrier, Amalgam, Operative | EKI | Class 1 | Dental | No | 2023-05-08 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 2017-01-13 |
| Preparer, Root Canal Endodontic | EKQ | Class 1 | Dental | No | 2023-01-17 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2026-06-01 |
| Zinc Oxide Eugenol | EMB | Class 1 | Dental | No | 2023-12-21 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2026-05-04 |
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
Any-Com Seal
Establishment Types
Manufacture Medical Device