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 |