The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Palaseal(r).
| Device ID | K892452 |
| 510k Number | K892452 |
| Device Name: | PALASEAL(R) |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | KULZER, INC. 111 N. WABASH AVE. Chicago, IL 60602 |
| Contact | Bauer, Phd |
| Correspondent | Bauer, Phd KULZER, INC. 111 N. WABASH AVE. Chicago, IL 60602 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-10 |
| Decision Date | 1989-06-16 |