Device Recall Septodont aka Novocol

  • Model / Serial
    Product Order Number 112-6966; Lot Number C4211-3; UPC Code *+H65811269662O*; Expiration Date September 2015.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to government/VA consignees.
  • Product Description
    Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure || Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Novocol, Inc., 416 S Taylor Ave, Louisville CO 80027-3028
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Product Order Number 950-9119; Lot Number C4211-3; UPC Code *950-9119*; Expiration Date September 2015.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was sent to two wholsalers/distributors in PA and NY. No product was distributed outside of the US or to government/VA consignees.
  • Product Description
    Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restorative material to the tooth during restorations. Package contains 100 0.125 mL unit dose tips, 100 applicator brushes, and a product insert.
  • Manufacturer