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Danville Materials, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
16
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2530-2016Class IIPerioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile componenJune 24, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K152349Star+ VPS Scannable Impression MaterialNovember 23, 2015
K151514PrestigeSeptember 21, 2015
K151088DMRC Bulk FillAugust 28, 2015
K142886DMRC Self-Cure Bracket Adhesive One Step and PrimerMarch 18, 2015
K142881DMRC Dual Cure Orthodontic Band CementFebruary 13, 2015
K121880DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUIDSeptember 25, 2012
K111876Z BOND, PRELUDE ONESeptember 21, 2011
K110642SILJETR SYSTEMMay 27, 2011
K102753TURBO TEMP 3February 4, 2011
K092912STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90December 16, 2009
K092319STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387September 16, 2009
K090106PRELUDE ONEMarch 31, 2009
K040952PRELUDEJune 29, 2004
K033215PREPAIRJanuary 9, 2004
K020760STARFLOW HVMay 3, 2002
K012354SNOWPOST, SNOWLIGHTOctober 10, 2001