The following data is part of a premarket notification filed by Maruchi with the FDA for Endoseal Mta.
| Device ID | K170175 |
| 510k Number | K170175 |
| Device Name: | ENDOSEAL MTA |
| Classification | Resin, Root Canal Filling |
| Applicant | MARUCHI 2-208, 42-10, Taejanggongdan-gil Wonju-si, KR 26311 |
| Contact | Jang Sung Wook |
| Correspondent | Priscilla Chung LK CONSULTING GROUP USA, INC 800 Roosevelt STE 417 Irvine, CA 92620 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-19 |
| Decision Date | 2018-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800071200000 | K170175 | 000 |