Ultradent Products, Inc.

6 devices in the database

  • Model / Serial
    lot#s BC2GN and BC4L7
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Austria, Canada, Colombia, Denmark, France, Germany, Great Britain, Iceland, and Portugal.
  • Product Description
    InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 || Product Usage: || InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel preparations as well as air abrasion.
  • Model / Serial
    Lot number: B6Z4K.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. || The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel, porcelain, metal and composite.
  • Model / Serial
    Part No. 5012, Lot No. B7PPC
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.
  • Model / Serial
    Lot No. B7DS3
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.
  • Model / Serial
    Lot R131360
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution including the states of CA, AZ, CO and WA.
  • Product Description
    Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, || Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.
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One manufacturer with a similar name

Learn more about the data here

  • Manufacturer Address
    Ultradent Products, Inc., 505 W 10200 S, South Jordan UT 84095-3800
  • Manufacturer Parent Company (2017)
  • Source
    USFDA