The following data is part of a premarket notification filed by Maruchi with the FDA for Endocem Zr.
| Device ID | K133042 |
| 510k Number | K133042 |
| Device Name: | ENDOCEM ZR |
| Classification | Resin, Root Canal Filling |
| Applicant | MARUCHI 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92833 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung MARUCHI 2651 E CHAPMAN AVE STE 110 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 | 2013-09-27 |
| Decision Date | 2014-05-12 |
| Summary: | summary |