The following data is part of a premarket notification filed by Cagenix Inc. with the FDA for Accuframe.
Device ID | K081157 |
510k Number | K081157 |
Device Name: | ACCUFRAME |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | CAGENIX INC. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
Contact | Linda K Schulz |
Correspondent | Linda K Schulz CAGENIX INC. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
Product Code | NHA |
CFR Regulation Number | 872.3630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-04-23 |
Decision Date | 2008-07-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
90860002441934 | K081157 | 000 |
90860002441927 | K081157 | 000 |
90860002441910 | K081157 | 000 |
90860002441903 | K081157 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ACCUFRAME 85973602 4504536 Live/Registered |
Schettine Associates, Inc. 2013-06-29 |
![]() ACCUFRAME 85867198 not registered Dead/Abandoned |
EULA TECHNOLOGIES, LLC 2013-03-05 |
![]() ACCUFRAME 79316633 not registered Live/Pending |
CLAY PAKY S.p.A. 2021-03-15 |
![]() ACCUFRAME 77408724 3632572 Live/Registered |
Cagenix, Inc. 2008-02-28 |
![]() ACCUFRAME 75474952 2426024 Dead/Cancelled |
PNC2, INC. 1998-04-27 |
![]() ACCUFRAME 75446542 not registered Dead/Abandoned |
Progressive Tool & Industries Co. 1998-03-09 |
![]() ACCUFRAME 75047958 not registered Dead/Abandoned |
AGCO Corporation 1996-01-22 |