The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Premise Flowable Modified.
| Device ID | K093484 |
| 510k Number | K093484 |
| Device Name: | PREMISE FLOWABLE MODIFIED |
| Classification | Material, Tooth Shade, Resin |
| Applicant | KERR CORPORATION 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Contact | Wendy Garman |
| Correspondent | Wendy Garman KERR CORPORATION 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-09 |
| Decision Date | 2010-01-27 |
| Summary: | summary |