The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for W-5.
Device ID | K022811 |
510k Number | K022811 |
Device Name: | W-5 |
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 | 2002-08-23 |
Decision Date | 2002-10-09 |