The following data is part of a premarket notification filed by Syntex Corp. with the FDA for Amalgam Alloy.
| Device ID | K780997 |
| 510k Number | K780997 |
| Device Name: | AMALGAM ALLOY |
| Classification | Alloy, Amalgam |
| Applicant | SYNTEX CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EJJ |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-14 |
| Decision Date | 1978-07-27 |