The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Premise Flowable.
| Device ID | K060472 |
| 510k Number | K060472 |
| Device Name: | PREMISE FLOWABLE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | KERR CORPORATION 100 BAYVIEW CIRCLE STE 6000 Newport Beach, CA 92660 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell KERR CORPORATION 100 BAYVIEW CIRCLE STE 6000 Newport Beach, CA 92660 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-23 |
| Decision Date | 2006-04-28 |
| Summary: | summary |