Manufacturer registered with FDA
Mediclus Co., Ltd
Cheongju-si, South Korea. Lists 16 dental device types with FDA across 1 registered establishment, and holds 15 510(k) clearances as applicant.
- Device types listed
- 16
- Brands and models
- 43
- 510(k) clearances
- 152023–2026
- Markets registered in
- 1064 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 10 markets
Where regulators' registries name Mediclus Co., Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Mediclus Co., Ltd | 15 clearances | 2023–2026 | Below |
| European Union | EUDAMED | Manufacturer | MEDICLUS Co., Ltd. | 30 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | MEDICLUS CO., LTD | 14 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Mediclus co., ltdMEDICLUS CO., LTD. | 7 | — | Pure Global AI |
| China | NMPA | Registration holder | 韩国美迪株式会社MEDICLUS CO., LTD.韩国美迪株式会社MEDICLUS CO., LTD.（(주)메디클러스） · 韩国美迪株式会社Mediclus Co.,Ltd (주)메디클러스 | 4 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | MEDICLUS CO., LTD. | 3 | 2024–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | Mediclus Co Ltd | 2 | 2018–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | Mediclus Co. LtdMediclus Co., Ltd. | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | MEDICLUS CO., LTD. | 1 | 2026–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Mediclus Co., Ltd. | 1 | 2025–2025 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Mediclus Co., Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Any-ComAny-Com BulkAny-Com FlowAny-Com KitAny-Com Universal KitAny-CoreHi-Bond UniversalOnce-Fil FlowOne-Temp Flow | 2023 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | Any-PasteBLSEALBLSEAL PuttyCanalPro CalciSealOne-FilOne-Fil PuttyOne-Fil Putty Injectable | 2024 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | Any-Com KitAny-Com Universal KitAny-EtchHi-Bond Universal | 2023 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | Any-Com Seal | 2026 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Block Out Resin DualEzi-SepLC-ResinThe-SEP | 2018 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Disposable Tip | 2026 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Dentto-Dam | 2017 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Any-Zircos | 2026 |
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Maker | One-Fil LC | 2026 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Desens Bio-CareDESENS BIO-CARE care kitW-Gel Premium | 2025 |
| Operative Amalgam CarrierEKI · Class 1 | Dental hand instruments | Maker | Ezi-StickEzi-Stick plus | 2023 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Maker | Endo@Prep EDTA CreamEndo@Prep EDTA GelMD-Solution | 2023 |
| Dental CementEMA · Class 2 | Dental cements | Maker | Any-Cem | 2026 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | Any-Temp Eugenol | 2023 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | Any-Com KitAny-Com Universal KitHi-Bond Universal | 2023 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Any-Print SG | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Mediclus Co., Ltd as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 21 Aug 2026 | K262074 | Any-Zircos | EIH Porcelain Powder |
| 13 Aug 2026 | K254201 | Any-Cem | EMA Dental Cement |
| 21 Jul 2026 | K261728 | One-Fil LC | EJK Calcium Hydroxide Cavity Liner |
| 14 May 2026 | K260485 | Any-Etch | KLE Resin Tooth Bonding Agent |
| 1 May 2026 | K260819 | Any-Com Seal | EBC Pit and Fissure Sealant and Conditioner |
| 12 Jan 2026 | K253167 | Any-Paste | KIF Root Canal Filling Resin |
| 5 Dec 2025 | K252465 | Any-Core | EBF Resin Tooth Shade Material |
| 22 Aug 2025 | K251884 | One-Fil Putty Injectable | KIF Root Canal Filling Resin |
| 6 Jun 2025 | K251283 | Once-Fil Flow | EBF Resin Tooth Shade Material |
| 14 Apr 2025 | K250823 | Any-Com Flow | EBF Resin Tooth Shade Material |
| 14 Mar 2025 | K243353 | One-Fil Putty | KIF Root Canal Filling Resin |
| 7 Feb 2025 | K242713 | Any-Com Bulk | EBF Resin Tooth Shade Material |
| 26 Sep 2024 | K241147 | Any-Com | EBF Resin Tooth Shade Material |
| 26 Jan 2024 | K232182 | One-Fil | KIF Root Canal Filling Resin |
| 22 May 2023 | K230465 | Hi-Bond Universal | KLE Resin Tooth Bonding Agent |
Some of these clearances are listed with FDA today by another company: Digital Arches Inc. (1), COLTENE Holding AG (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MEDICLUS CO., LTDFDA reg. 3013584861 | Cheongju-si Chungbuk, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10053816). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.