The following data is part of a premarket notification filed by Imtec Corp. with the FDA for Secure Reline/pickup Material.
| Device ID | K021586 |
| 510k Number | K021586 |
| Device Name: | SECURE RELINE/PICKUP MATERIAL |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | IMTEC CORP. 2401 NORTH COMMERCE Ardmore, OK 73401 |
| Contact | Brad Vance |
| Correspondent | Brad Vance IMTEC CORP. 2401 NORTH COMMERCE Ardmore, OK 73401 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-14 |
| Decision Date | 2002-06-14 |