The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Temp. Crown Msterial For Teeth.
| Device ID | K781244 |
| 510k Number | K781244 |
| Device Name: | TEMP. CROWN MSTERIAL FOR TEETH |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | DEN-MAT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-07-19 |
| Decision Date | 1978-08-31 |