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Ormco Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
40
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K141611LYTHOS DIGITAL IMPRESSION SYSTEMDecember 5, 2014
K123118INSIGNIA DIGICASTMarch 26, 2013
K123416INSIGNIA WITH ITEROMarch 13, 2013
K122065DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USEFebruary 8, 2013
K121524INSIGNIAAugust 9, 2012
K112640HYPERELASTIC WIRENovember 16, 2011
K101676CLEARARCHSeptember 13, 2010
K081900TEMPORARY TOOTH REPLACEMENTOctober 24, 2008
K081415DAMON 4CLEARSeptember 24, 2008
K062856TF ROTARY NICKEL TITANIUM FILEDecember 13, 2006
K061481GRENGLOOJuly 6, 2006
K052477DAMON 3 MODIFIEDNovember 30, 2005
K955333SPIRIT MBJanuary 4, 1996
K951239GLOWING SPIRITSJuly 19, 1995
K951776BAND SEATERMay 23, 1995
K946255THERMASETJanuary 27, 1995
K943068MAGNEFORCEAugust 17, 1994
K941015ORMCO SYSTEM 1+ (TM)March 31, 1994
K922806ORMCO SPORTSGUARDOctober 20, 1993
K923405THE HERBST APPLIANCEMay 5, 1993