Devices

Device Recall IMPAK Liquid Acrylic Resin

  • Model / Serial
    Lot Number 103113
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, to the states of MI, NJ, PA, and TX; and, the country of Canada.
  • Product Description
    IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748. || Indicated for relining a denture surface for repairing a fractured denture, or forming a new denture base.
  • Manufacturer
    CMP Industries, Llc
  • 1 Event

Manufacturer

CMP Industries, Llc
  • Manufacturer Address
    CMP Industries, Llc, 413 N Pearl St, Albany NY 12207-1311
  • Manufacturer Parent Company (2017)
    CMP Industries, Llc
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall IMPAK Liquid Acrylic Resin
  • Model / Serial
    Lot Number 101113
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including CA, MI, LA, OH, NY, IN, WA; Internationally: to CA
  • Product Description
    IMPAK Liquid Acrylic Resin sold under the following labels: || 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part No. 3314 || 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325 cc), Part No. 3748 || 3) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, 1 Quart (946 cc), P/N 3306 || 4) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid PN 7450, || 5) ThermoFlex ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS 1 Quart (946 cc) P/N 7465 || Indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base
  • Manufacturer
    CMP Industries, Llc