The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Palabond.
Device ID | K924422 |
510k Number | K924422 |
Device Name: | PALABOND |
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 | 1992-09-01 |
Decision Date | 1992-11-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PALABOND 76048256 2566653 Live/Registered |
KULZER GMBH 2000-05-12 |