The following data is part of a premarket notification filed by Wallace A. Erickson & Co. with the FDA for Centrix Flofil/centrix Flofil With Fluoride.
| Device ID | K960667 |
| 510k Number | K960667 |
| Device Name: | CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | WALLACE A. ERICKSON & CO. 1920 NORTH CLYBOURN AVE. Chicago, IL 60614 |
| Contact | Abner T Dela Cruz |
| Correspondent | Abner T Dela Cruz WALLACE A. ERICKSON & CO. 1920 NORTH CLYBOURN AVE. Chicago, IL 60614 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-20 |
| Decision Date | 1996-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817051020976 | K960667 | 000 |
| 00817051020846 | K960667 | 000 |
| 00817051020853 | K960667 | 000 |
| 00817051020860 | K960667 | 000 |
| 00817051020877 | K960667 | 000 |
| 00817051020884 | K960667 | 000 |
| 00817051020891 | K960667 | 000 |
| 00817051020907 | K960667 | 000 |
| 00817051020914 | K960667 | 000 |
| 00817051020921 | K960667 | 000 |
| 00817051020938 | K960667 | 000 |
| 00817051020945 | K960667 | 000 |
| 00817051020952 | K960667 | 000 |
| 00817051020969 | K960667 | 000 |
| 00817051020839 | K960667 | 000 |