The following data is part of a premarket notification filed by Bego U.s.a. with the FDA for Gold Dental Casting Alloys.
Device ID | K033279 |
510k Number | K033279 |
Device Name: | GOLD DENTAL CASTING ALLOYS |
Classification | Alloy, Gold-based Noble Metal |
Applicant | BEGO U.S.A. 24 ALBION RD. SUITE 103 Lincoln, RI 02865 |
Contact | William Oremus |
Correspondent | William Oremus BEGO U.S.A. 24 ALBION RD. SUITE 103 Lincoln, RI 02865 |
Product Code | EJT |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-10-10 |
Decision Date | 2004-01-15 |