4 results
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23ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Iii
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Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
FDA Enforcement
Class III
·Terminated·Ultradent Products, Inc.·December 18, 2013
Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.
FDA Enforcement
Class III
·Terminated·Ultradent Products, Inc.·February 20, 2013
Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.
FDA Enforcement
Class III
·Terminated·Ultradent Products, Inc.·February 20, 2013
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.
FDA Enforcement
Class III
·Terminated·Ultradent Products, Inc.·March 6, 2013