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Imtec Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
28
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K081653MDI MII ONE-PIECE IMPLANT, 2.9MMSeptember 19, 2008
K081347ILUMA VISIONMay 28, 2008
K072660ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114December 12, 2007
K053046ILUMA ORTHOCAT/DENTALCATNovember 8, 2005
K043226ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320January 13, 2005
K042289MDI ORTHOSeptember 15, 2004
K033432LEXATITE QUICK ACRYLICJanuary 15, 2004
K031106IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XXAugust 12, 2003
K030243ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314April 23, 2003
K024044SABER TECH IMPLANTS SYSTEMFebruary 21, 2003
K023067IMTEC SENDAX MDI ORTHO6 AND ORTHO8December 3, 2002
K021437SECURE SOFTJuly 19, 2002
K021586SECURE RELINE/PICKUP MATERIALJune 14, 2002
K020396BIOCELLECT -PERIOApril 10, 2002
K010775BIOCELLECTJune 12, 2001
K982951IMTEC BIOPINJune 21, 1999
K990983MODIFICATION TO IMTEC SENDAX MDIApril 13, 1999
K974752IMTEC/BIOBARRIER MEMBRANEMarch 3, 1998
K973248IMTEC BONE COLLECTOR SYSTEMNovember 19, 1997
K973180IMTEC BONE TACNovember 18, 1997