The following data is part of a premarket notification filed by Degussa Ag with the FDA for Degufill (tm) Whit-sealant.
Device ID | K902742 |
510k Number | K902742 |
Device Name: | DEGUFILL (TM) WHIT-SEALANT |
Classification | Sealant, Pit And Fissure, And Conditioner |
Applicant | DEGUSSA AG 3950 SOUTH CLINTON AVE. South Plainfield, NJ 07080 |
Product Code | EBC |
CFR Regulation Number | 872.3765 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-22 |
Decision Date | 1990-09-12 |