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Coltene, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K041098COOL TEMP NATURALMay 13, 2004
K022224COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEMSeptember 18, 2002
K902392COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIALAugust 28, 1990
K882800COLTENE PRESIDENT JET REGULAR BODYSeptember 23, 1988
K873671COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEMOctober 27, 1987
K870266COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEMFebruary 27, 1987
K870047COLTENE RAPIDJanuary 29, 1987
K863998COLTENE JET-MIXEROctober 30, 1986
K850036COLTENE PRECISEFebruary 8, 1985
K840297COLTENE ORALLOY MAGICAPSMarch 16, 1984
K811667COLTENE PRESSURE SPOT INDICATORJuly 15, 1981
K811767COLTENE PRESIDENT IMPRESSION MATERIALSJuly 15, 1981
K811666COLTENE COLTEX/COLTOFLAXJuly 15, 1981
K811363COLTENE DRS DENTAL RESTORATIVE SYSTEMJune 16, 1981
K810907COLTENE ORALLYApril 23, 1981