The following data is part of a premarket notification filed by G-c Intl. Corp. with the FDA for Exaflex Impression Material.
| Device ID | K812406 |
| 510k Number | K812406 |
| Device Name: | EXAFLEX IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | G-C INTL. CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-21 |
| Decision Date | 1981-10-06 |