Devices

Device Recall InterGuard 5.5mm Econo Refill

Model / Serial
lot#s BC2GN and BC4L7
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - US Nationwide and the countries of Austria, Canada, Colombia, Denmark, France, Germany, Great Britain, Iceland, and Portugal.
Product Description
InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 || Product Usage: || InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel preparations as well as air abrasion.
Manufacturer
Ultradent Products, Inc.
1 Event
- Recall of Device Recall InterGuard 5.5mm Econo Refill

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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