Ultradent Products, Inc.

6 dispositifs dans la base de données

  • Modèle / numéro de série
    R&D; Lot Numbers:4519 - 4522, 4524 - 4527, 4530 - 4534, 4537 - 4548, 4550 - 4554, 4558 - 4612, 4618 - 4624
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including UT, CA, WA, VA, OH, and TN.
  • Description du dispositif
    Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets || Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
  • Modèle / numéro de série
    Lot R131360
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution including the states of CA, AZ, CO and WA.
  • Description du dispositif
    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.
  • Modèle / numéro de série
    Lot No. B7DS3
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.
  • Modèle / numéro de série
    Part No. 5012, Lot No. B7PPC
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.
  • Modèle / numéro de série
    Lot number: B6Z4K.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    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.
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  • Adresse du fabricant
    Ultradent Products, Inc., 505 W 10200 S, South Jordan UT 84095-3800
  • Société-mère du fabricant (2017)
  • Source
    USFDA