The following data is part of a premarket notification filed by Specialites Septodont with the FDA for Quickset Liquid And Powder.
Device ID | K982773 |
510k Number | K982773 |
Device Name: | QUICKSET LIQUID AND POWDER |
Classification | Cement, Dental |
Applicant | SPECIALITES SEPTODONT 1050 CONNECTICUT AVE. NW Washington, DC 20036 -5339 |
Contact | Peter S Reichertz |
Correspondent | Peter S Reichertz SPECIALITES SEPTODONT 1050 CONNECTICUT AVE. NW Washington, DC 20036 -5339 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-07 |
Decision Date | 1998-11-03 |