The following data is part of a premarket notification filed by Imtec Corp. with the FDA for Modification To Imtec Sendax Mdi.
| Device ID | K990983 |
| 510k Number | K990983 |
| Device Name: | MODIFICATION TO IMTEC SENDAX MDI |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMTEC CORP. 2401 NORTH COMMERCE Ardmore, OK 73401 |
| Contact | M.k. Patterson |
| Correspondent | M.k. Patterson IMTEC CORP. 2401 NORTH COMMERCE Ardmore, OK 73401 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-24 |
| Decision Date | 1999-04-13 |
| Summary: | summary |