Data / Medical devices / South Korea / Maruchi
Maruchi: FDA-registered device maker in Wonju-si Gangwon, South Korea, 5 510(k) clearances
Maruchi is registered with the FDA (registration 3009560600) in Wonju-si Gangwon, South Korea. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 14, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009560600
- Address
- 101, Donghwagongdan-ro, Munmak-eup, Wonju-si Gangwon, South Korea, 26365
- Owner or operator
- MARUCHI (10040294)
- Roles
- Manufacturer
- First device listed
- March 28, 2012
- Registered through
- 2026
- Brand names listed
- AH Plus® Bioceramic Sealer, AH Plus® Bioceramic Sealer Endodontic Cannulas, CleaniCal, ENDOCEM MTA, ENDOCEM MTA PREMIXED REGULAR, ENDOSEAL BIOCERAMIC SEALER, ENDOSEAL MTA, ENDOSONIC BLUE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| File, Pulp Canal, Endodontic | EKS | 1 | Manufacturer | accessdata.fda.gov |
| Liner, Cavity, Calcium Hydroxide | EJK | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Manufacturer | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 14, 2023 | K213757 | Endocem MTA Premixed Regular | KIF | Substantially Equivalent | Maruchi | accessdata.fda.gov |
| August 13, 2021 | K212229 | White Endoseal MTA | KIF | Substantially Equivalent | Maruchi | accessdata.fda.gov |
| February 12, 2021 | K201799 | CleaniCal | EJK | Substantially Equivalent | Maruchi | accessdata.fda.gov |
| February 26, 2018 | K170175 | ENDOSEAL MTA | KIF | Substantially Equivalent | Maruchi | accessdata.fda.gov |
| March 19, 2012 | K112078 | ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) | KIF | Substantially Equivalent | Maruchi | accessdata.fda.gov |
Compare with other makers
- All makers of Resin, Root Canal Filling
- All makers of File, Pulp Canal, Endodontic
- All makers of Liner, Cavity, Calcium Hydroxide
- All makers of Pick, Massaging
- All makers of Needle, Dental
Updated February 14, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.