Mediclus Co., Ltd
Cheongju-si Chungbuk, KR
MEDICLUS CO., LTD appears in FDA device records in Cheongju-si Chungbuk, KR. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Mediclus Co., Ltd between 2023 and 2026. The busiest year on record is 2025, with 6. The most recent is 2026, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 6 |
| 2026 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254201 | Any-Cem | EMA | Substantially Equivalent | |
| K261728 | One-Fil LC | EJK | Substantially Equivalent | |
| K260485 | Any-Etch | KLE | Substantially Equivalent | |
| K260819 | Any-Com Seal | EBC | Substantially Equivalent | |
| K253797 | One-Stop | MVL | Substantially Equivalent | |
| K253167 | Any-Paste | KIF | Substantially Equivalent | |
| K252465 | Any-Core | EBF | Substantially Equivalent | |
| K251884 | One-Fil Putty Injectable | KIF | Substantially Equivalent | |
| K251283 | Once-Fil Flow | EBF | Substantially Equivalent | |
| K250823 | Any-Com Flow | EBF | Substantially Equivalent | |
| K243353 | One-Fil Putty | KIF | Substantially Equivalent | |
| K242713 | Any-Com Bulk | EBF | Substantially Equivalent | |
| K241147 | Any-Com | EBF | Substantially Equivalent | |
| K232182 | One-Fil | KIF | Substantially Equivalent | |
| K230465 | Hi-Bond Universal | KLE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013584861 | 3013584861 | MEDICLUS CO., LTD | No. 1210, 134 Gongdan-ro, Heungdeok-gu, Cheongju-si Chungbuk 28576 KR | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NDPAccessories, Implant, Dental, Endosseous
- EJRAgent, Polishing, Abrasive, Oral Cavity
- KLEAgent, Tooth Bonding, Resin
- EKICarrier, Amalgam, Operative
- EMACement, Dental
- MVLCord, Retraction
- EIEDam, Rubber
- EJKLiner, Cavity, Calcium Hydroxide
- EBFMaterial, Tooth Shade, Resin
- EIHPowder, Porcelain
- EKQPreparer, Root Canal Endodontic
- KIFResin, Root Canal Filling
- EBCSealant, Pit And Fissure, And Conditioner
- EIDSyringe, Restorative And Impression Material
- LBHVarnish, Cavity
- EGDWax, Dental, Intraoral
- EMBZinc Oxide Eugenol
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain