The following data is part of a premarket notification filed by Degussa Dental, Inc. with the FDA for Estic Microfill.
Device ID | K780833 |
510k Number | K780833 |
Device Name: | ESTIC MICROFILL |
Classification | Material, Tooth Shade, Resin |
Applicant | DEGUSSA DENTAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-05-22 |
Decision Date | 1978-06-14 |