The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Will-ceram Brushes, Super Brush Kit.
Device ID | K905328 |
510k Number | K905328 |
Device Name: | WILL-CERAM BRUSHES, SUPER BRUSH KIT |
Classification | Powder, Porcelain |
Applicant | IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Contact | Gary L Severance |
Correspondent | Gary L Severance IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-28 |
Decision Date | 1991-01-17 |