FDA-Device2013-03-06Class III
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.
Ultradent Products, Inc.
Hazard
Orthodontic brackets distributed was incorrectly labeled.
Sold states
USA Nationwide Distribution including the states of CA, AZ, CO and WA.
Affected count
124
Manufactured in
505 W 10200 S, N/A, South Jordan, UT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0876-2013Don't want to check this manually?
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