Manufacturer registered with FDA
Maruchi
Wonju-si, South Korea. Lists 5 dental device types with FDA across 1 registered establishment, and holds 8 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 26
- 510(k) clearances
- 82012–2023
- Markets registered in
- 1025 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 10 markets
Where regulators' registries name Maruchi 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 | Maruchi | 8 clearances | 2012–2023 | Below |
| European Union | EUDAMED | Manufacturer | MARUCHI | 5 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | MARUCHI CO. LTDMARUCHI | 4 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | MARUCHI | 4 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MARUCHI | 4 | 2018–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Maruchi | 2 | 2014–2023 | Pure Global AI |
| Israel | AMAR | Manufacturer | MARUCHIMaruchi | 2 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Maruchi | 2 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | MARUCHI | 1 | 2022–2022 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | MARUCHI | 1 | 2026–2026 | 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 Maruchi currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | AH Plus® Bioceramic SealerCleaniCalENDOCEM MTAENDOCEM MTA PREMIXED REGULARENDOSEAL BIOCERAMIC SEALERENDOSEAL MTASendoCem MTASendoSeal MTAWhite ENDOSEAL Bioceramic SealerWhite ENDOSEAL MTA | 2012 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | AH Plus® Bioceramic Sealer Endodontic Cannulas | 2021 |
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Maker | CleaniCal | 2021 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | EndoRoadEndoRoad NEndoRoad PEndoRoad SENDOSONIC BLUEENDOSONIC BLUE EMSENDOSONIC BLUE Ni-Ti FileENDOSONIC BLUE Ni-Ti File 2ENDOSONIC BLUE PLUSEndoSonic Metal 2 morePP fileVPT Orifice Shaper | 2015 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | ENDOSONIC BLUE KITENDOSONIC BLUE PORTABLE | 2019 |
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 Maruchi as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 14 Feb 2023 | K213757 | Endocem MTA Premixed Regular | KIF Root Canal Filling Resin |
| 13 Aug 2021 | K212229 | White Endoseal MTA | KIF Root Canal Filling Resin |
| 24 Mar 2021 | K202015 | White ENDOSEAL MTA | KIF Root Canal Filling Resin |
| 12 Feb 2021 | K201799 | CleaniCal | EJK Calcium Hydroxide Cavity Liner |
| 26 Feb 2018 | K170175 | ENDOSEAL MTA | KIF Root Canal Filling Resin |
| 12 May 2014 | K133054 | ENDOSEAL | KIF Root Canal Filling Resin |
| 12 May 2014 | K133042 | ENDOCEM ZR | KIF Root Canal Filling Resin |
| 19 Mar 2012 | K112078 | ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) | KIF Root Canal Filling Resin |
Some of these clearances are listed with FDA today by another company: Directa AB (2), Dentsply Sirona, Inc. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MARUCHIFDA reg. 3009560600 | Wonju-si Gangwon, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10040294). 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.