The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Proceram Porcelain.
| Device ID | K903907 |
| 510k Number | K903907 |
| Device Name: | PROCERAM PORCELAIN |
| Classification | Teeth, Porcelain |
| Applicant | NOBELPHARMA USA, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Contact | Ronald Dudek |
| Correspondent | Ronald Dudek NOBELPHARMA USA, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Product Code | ELL |
| CFR Regulation Number | 872.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-23 |
| Decision Date | 1990-11-09 |