The following data is part of a premarket notification filed by Imtec Corp. with the FDA for Endure Implant, Model 3508,3511,3514,4308,4311,4314.
| Device ID | K030243 |
| 510k Number | K030243 |
| Device Name: | ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 |
| 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 | 2003-01-23 |
| Decision Date | 2003-04-23 |