The following data is part of a premarket notification filed by Imtec Corp. with the FDA for Imtec Sendax Mdi And Mdi Plus Endosseous Implant, Models Ob-xx, Sh-xx, Mob-22, Msh-xx.
| Device ID | K031106 |
| 510k Number | K031106 |
| Device Name: | IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMTEC CORP. 2401 NORTH COMMERCE Ardmore, OK 73401 |
| Contact | J. Brad Vance |
| Correspondent | J. Brad Vance IMTEC CORP. 2401 NORTH COMMERCE Ardmore, OK 73401 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-08 |
| Decision Date | 2003-08-12 |