The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Bright Gold.
Device ID | K021892 |
510k Number | K021892 |
Device Name: | BRIGHT GOLD |
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 | 2002-06-07 |
Decision Date | 2002-07-25 |