Devices

Device Recall Opal Orthodontics by Ultradent

Model / Serial
R&D; Lot Numbers:4519 - 4522, 4524 - 4527, 4530 - 4534, 4537 - 4548, 4550 - 4554, 4558 - 4612, 4618 - 4624
Product Classification
Dental Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including UT, CA, WA, VA, OH, and TN.
Product Description
Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets || Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
Manufacturer
Ultradent Products, Inc.
1 Event
- Recall of Device Recall Opal Orthodontics by Ultradent

Manufacturer

Ultradent Products, Inc.

Manufacturer Address
Ultradent Products, Inc., 505 W 10200 S, South Jordan UT 84095-3935
Manufacturer Parent Company (2017)
Ultradent Products Inc
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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