The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for (cp) Titanium And Ti6ai-4v Alloy For Fixed Prosthe.
| Device ID | K901552 |
| 510k Number | K901552 |
| Device Name: | (CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE |
| Classification | Alloy, Metal, Base |
| 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 | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-03 |
| Decision Date | 1991-06-24 |