The following data is part of a premarket notification filed by Imtec Corp. with the FDA for Endure Implant, Models 3508, 4308, 3520, 4320.
| Device ID | K043226 |
| 510k Number | K043226 |
| Device Name: | ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 |
| 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 | 2004-11-22 |
| Decision Date | 2005-01-13 |