The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Quicksplint.
| Device ID | K961995 |
| 510k Number | K961995 |
| Device Name: | QUICKSPLINT |
| 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 | 1996-05-21 |
| Decision Date | 1996-06-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() QUICKSPLINT 87081743 5231021 Live/Registered |
QuickSplint, LLC 2016-06-23 |
![]() QUICKSPLINT 85115766 not registered Dead/Abandoned |
Bradley A. Eli Dental Corporation 2010-08-25 |
![]() QUICKSPLINT 74272191 1753773 Live/Registered |
Campbell, Blair 1992-05-04 |
![]() QUICKSPLINT 74114610 not registered Dead/Abandoned |
Campbell, Blair 1990-11-13 |