The following data is part of a premarket notification filed by Mediscitec Inc. with the FDA for M.
| Device ID | K092542 |
| 510k Number | K092542 |
| Device Name: | M |
| Classification | Implant, Endosseous, Root-form |
| Applicant | MEDISCITEC INC. 5401 S. COTTONWOOD COURT Greenwood Village, CO 80121 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls MEDISCITEC INC. 5401 S. COTTONWOOD COURT Greenwood Village, CO 80121 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-19 |
| Decision Date | 2010-04-23 |