The following data is part of a premarket notification filed by Prometal Technologies with the FDA for Prometal Hn86.
| Device ID | K052463 |
| 510k Number | K052463 |
| Device Name: | PROMETAL HN86 |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | PROMETAL TECHNOLOGIES 67 MAIN STREET Silver Creek, NY 14136 |
| Contact | Donna Marie Hartnett |
| Correspondent | Donna Marie Hartnett PROMETAL TECHNOLOGIES 67 MAIN STREET Silver Creek, NY 14136 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-08 |
| Decision Date | 2005-10-14 |