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Dec 18, 2013
Published: 2013-12-18Captured: 2026-02-09Ultradent Products, Inc.Product: Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
FDA issued a Class III enforcement action. Affects Ultradent Products, Inc.. Reason: Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process wa.
- •Classification: Class III
- •Firm: Ultradent Products, Inc.
- •Status: Terminated
- •Distribution: Nationwide Distribution including UT, CA, WA, VA, OH, and TN.
Reason
Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.
Status:Terminated
Distribution:Nationwide Distribution including UT, CA, WA, VA, OH, and TN.
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