The following data is part of a premarket notification filed by Degussa Ag with the FDA for Degufill (tm).
Device ID | K902745 |
510k Number | K902745 |
Device Name: | DEGUFILL (TM) |
Classification | Material, Tooth Shade, Resin |
Applicant | DEGUSSA AG 3950 SOUTH CLINTON AVE. South Plainfield, NJ 07080 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-22 |
Decision Date | 1990-08-13 |