The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Durafill Flow.
| Device ID | K904555 |
| 510k Number | K904555 |
| Device Name: | DURAFILL FLOW |
| Classification | Material, Tooth Shade, Resin |
| Applicant | KULZER, INC. 10005 MUIRLANDS BLVD. UNIT G. Irvine, CA 92718 |
| Contact | Sharon Parker |
| Correspondent | Sharon Parker KULZER, INC. 10005 MUIRLANDS BLVD. UNIT G. Irvine, CA 92718 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-05 |
| Decision Date | 1990-11-13 |