The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Durafill Microfill Restorative Material.
| Device ID | K811669 |
| 510k Number | K811669 |
| Device Name: | DURAFILL MICROFILL RESTORATIVE MATERIAL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | KULZER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-15 |
| Decision Date | 1981-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J014660024990 | K811669 | 000 |
| J014660000170 | K811669 | 000 |
| J014660000160 | K811669 | 000 |
| J014660000150 | K811669 | 000 |
| J014660000140 | K811669 | 000 |
| J014660000130 | K811669 | 000 |
| J014660000120 | K811669 | 000 |
| J014660000110 | K811669 | 000 |
| J014660000100 | K811669 | 000 |
| J014660000090 | K811669 | 000 |
| J014660000180 | K811669 | 000 |
| J014660000190 | K811669 | 000 |
| J014660000200 | K811669 | 000 |
| J014660000300 | K811669 | 000 |
| J014660000290 | K811669 | 000 |
| J014660000280 | K811669 | 000 |
| J014660000270 | K811669 | 000 |
| J014660000260 | K811669 | 000 |
| J014660000250 | K811669 | 000 |
| J014660000230 | K811669 | 000 |
| J014660000220 | K811669 | 000 |
| J014660000210 | K811669 | 000 |
| J014660000080 | K811669 | 000 |