Devices

Device Recall Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires.

Model / Serial
Model: 001. P/N: 11219251124; Lot # 34415.
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution; Nationwide (USA) distribution including the states of NV, CT, and FL; and the countries of Australia and Turkey.
Product Description
Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires. || Packaged in 19 packages of 100 and 6 packages of 10. || Highland Metals, Inc. || Wire used for orthodontic treatment to place in the brackets to shape teeth.
Manufacturer
Highland Metals
1 Event
- Recall of Device Recall Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires.

Manufacturer

Highland Metals

Manufacturer Address
Highland Metals, 419 Perrymont Ave, San Jose CA 95125-1445
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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