The following data is part of a premarket notification filed by Aleaciones Dentales Zeyco, S.a. De C.v. with the FDA for Mercury Dental.
| Device ID | K973548 |
| 510k Number | K973548 |
| Device Name: | MERCURY DENTAL |
| Classification | Mercury |
| Applicant | ALEACIONES DENTALES ZEYCO, S.A. DE C.V. CALZ. LAZARO CARDENAS #2838 COL. JARDINES DEL BOSQUE Guadalajara, MX 44520 |
| Contact | Jorge Zepeda Galvez |
| Correspondent | Jorge Zepeda Galvez ALEACIONES DENTALES ZEYCO, S.A. DE C.V. CALZ. LAZARO CARDENAS #2838 COL. JARDINES DEL BOSQUE Guadalajara, MX 44520 |
| Product Code | ELY |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-18 |
| Decision Date | 1998-03-23 |