The following data is part of a premarket notification filed by Csmimplant with the FDA for Csm Submerged-r Implant System.
| Device ID | K111120 |
| 510k Number | K111120 |
| Device Name: | CSM SUBMERGED-R IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | CSMIMPLANT 325 N. PUENTE ST. UNIT B Brea, CA 92821 |
| Contact | April Lee |
| Correspondent | April Lee CSMIMPLANT 325 N. PUENTE ST. UNIT B Brea, CA 92821 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-21 |
| Decision Date | 2011-10-14 |
| Summary: | summary |