The following data is part of a premarket notification filed by Imtec Corp. with the FDA for Lexatite Quick Acrylic.
| Device ID | K033432 |
| 510k Number | K033432 |
| Device Name: | LEXATITE QUICK ACRYLIC |
| Classification | Crown And Bridge, Temporary, Resin |
| 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 | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-28 |
| Decision Date | 2004-01-15 |