The following data is part of a premarket notification filed by Maruchi with the FDA for White Endoseal Mta.
| Device ID | K202015 |
| 510k Number | K202015 |
| Device Name: | White ENDOSEAL MTA |
| Classification | Resin, Root Canal Filling |
| Applicant | Maruchi 2-208, Medical Industry Complex Bldg., 42-10, Taejanggongdan-gil Wonju-si, KR 26311 |
| Contact | Sung Wook Jang |
| Correspondent | Sung Wook Jang Maruchi 2-208, Medical Industry Complex Bldg., 42-10, Taejanggongdan-gil Wonju-si, KR 26311 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-21 |
| Decision Date | 2021-03-24 |