The following data is part of a premarket notification filed by Maruchi with the FDA for Endocem Mta (mineral Trioxide Aggregate).
| Device ID | K112078 |
| 510k Number | K112078 |
| Device Name: | ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) |
| Classification | Resin, Root Canal Filling |
| Applicant | MARUCHI 951 STARBUCK ST. UNIT J Fullerton, CA 92833 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung MARUCHI 951 STARBUCK ST. UNIT J Fullerton, CA 92833 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-21 |
| Decision Date | 2012-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800071200079 | K112078 | 000 |