The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Biouniversal Pkf.
| Device ID | K030435 |
| 510k Number | K030435 |
| Device Name: | BIOUNIVERSAL PKF |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Anderjeet Gulati |
| Correspondent | Anderjeet Gulati IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-10 |
| Decision Date | 2003-04-15 |