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Ivoclar North America, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
131
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K012174ERIS LAYERING MATERIALSAugust 27, 2001
K011491HELIOSEAL CLEAR CHROMAAugust 16, 2001
K011492IN TEN-SJuly 5, 2001
K011490MODIFICATION TO EXCITEJune 27, 2001
K011023D.SIGN 96May 2, 2001
K011022BIOUNIVERSAL PDFMay 2, 2001
K010381D.SIGN 30March 6, 2001
K010250TETRIC CERAM HBFebruary 28, 2001
K003293EXCITE DSCFebruary 6, 2001
K003407SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER)January 26, 2001
K003635DW 276 #3December 22, 2000
K003634DW 272 #1December 21, 2000
K003633DW 277 #4December 20, 2000
K003632DW 273 #1December 20, 2000
K003377FERMIT N PLUSDecember 4, 2000
K003374FERMIT PLUSDecember 4, 2000
K003373PROCAD ADD-ONNovember 28, 2000
K002872R&D PROJECT DW271#11ANovember 2, 2000
K001469R&D PROJECT DW269#25July 5, 2000
K993783TETRIC FLOWDecember 13, 1999