The following data is part of a premarket notification filed by Maruchi with the FDA for White Endoseal Mta.
| Device ID | K212229 |
| 510k Number | K212229 |
| 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 | Jang Sung Wook |
| Correspondent | Jang Sung Wook 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-16 |
| Decision Date | 2021-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D075BKTAHBS0000001 | K212229 | 000 |
| D075B00AHBS10003G2 | K212229 | 000 |
| 08800071200093 | K212229 | 000 |