The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Paladur.
| Device ID | K915898 |
| 510k Number | K915898 |
| Device Name: | PALADUR |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | HERAEUS KULZER, INC. 10005 MUIRLANDS BLVD. Irvine, CA 92718 -2595 |
| Contact | Sharon Parker |
| Correspondent | Sharon Parker HERAEUS KULZER, INC. 10005 MUIRLANDS BLVD. Irvine, CA 92718 -2595 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-12 |
| Decision Date | 1992-09-16 |