The following data is part of a premarket notification filed by Bego U.s.a. with the FDA for Bio Pontostar.
| Device ID | K983077 |
| 510k Number | K983077 |
| Device Name: | BIO PONTOSTAR |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | BEGO U.S.A. 1088 MAIN ST. SUITE 200 Pawtucket, RI 02860 |
| Contact | William Oremus |
| Correspondent | William Oremus BEGO U.S.A. 1088 MAIN ST. SUITE 200 Pawtucket, RI 02860 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-02 |
| Decision Date | 1998-10-23 |