CMP Industries, Llc

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
7
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0292-2019Class IIIMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product USeptember 12, 2018
Z-0293-2019Class IITechnoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 REF: 3748GB. ProducSeptember 12, 2018
Z-2098-2016Class IIIMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml LiquApril 28, 2016
Z-2097-2016Class IIIMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOApril 28, 2016
Z-2089-2016Class IIIMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIMarch 2, 2016
Z-1089-2016Class IIIMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, November 18, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K170423DentureID MicrochipOctober 25, 2017
K170375Nobilplast Denture ResinOctober 2, 2017
K072851POLYSTAR 79 DENTURE BASE RESINFebruary 20, 2008
K072402FLEX-STAR VOctober 19, 2007
K033020IMPAK ACRYLIC REPAIR RESIN LIQUIDDecember 19, 2003
K953594VULCANSeptember 5, 1995
K902972FLEXOR (DENTURE ACRYLIC RELINE MATERIAL)October 4, 1990