The following data is part of a premarket notification filed by Ivoclar Usa, Inc. with the FDA for High Gold Palladium Free Ceramic Solder.
| Device ID | K012877 |
| 510k Number | K012877 |
| Device Name: | HIGH GOLD PALLADIUM FREE CERAMIC SOLDER |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | IVOCLAR USA, INC. 175 PINEVIEW DR. Amherst, NY 14150 |
| Contact | Anderjeet Gulati |
| Correspondent | Anderjeet Gulati IVOCLAR USA, INC. 175 PINEVIEW DR. Amherst, NY 14150 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-27 |
| Decision Date | 2001-11-21 |