FDA-Device2013-12-18Class III
Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
Ultradent Products, Inc.
Hazard
Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.
Sold states
Nationwide Distribution including UT, CA, WA, VA, OH, and TN.
Affected count
217 units
Manufactured in
505 W 10200 S, South Jordan, UT, United States
Products
Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0481-2014Don't want to check this manually?
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