The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for New Opaque Porcelain.
| Device ID | K915543 |
| 510k Number | K915543 |
| Device Name: | NEW OPAQUE PORCELAIN |
| Classification | Powder, Porcelain |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Contact | Jeffery Lehn |
| Correspondent | Jeffery Lehn DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-10 |
| Decision Date | 1992-03-19 |