PALASPLINT
Resin, Denture, Relining, Repairing, Rebasing
HERAEUS KULZER, INC.
The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Palasplint.
Pre-market Notification Details
| Device ID | K953743 |
| 510k Number | K953743 |
| Device Name: | PALASPLINT |
| 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 | 1995-08-09 |
| Decision Date | 1995-10-02 |
Trademark Results [PALASPLINT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PALASPLINT 75202897 2209567 Dead/Cancelled |
HERAEUS KULZER GMBH 1996-11-22 |
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