Devices

Device Recall Orthos CM Bracket, Orthodontic Metal Bracket,

Model / Serial
Part Number: Lot Number: 454-1210 08H599H 454-0210 08H358H, 08J174J, and 08J175J
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and worldwide to Canada, Colombia, Hong Kong, Kuwait, United Arab Emirates, Mexico, Russia, South Africa, Croatia, Japan, France, Bulgaria, Germany, Estonia, United Kingdom, Hungary, Ireland, Italy, Netherlands, Australia, and New Zealand.
Product Description
Brand name: Orthos CM Bracket, Orthodontic Metal Bracket, || Part Numbers: 454-1210, 454-0210. || The intended use of this device is a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
Manufacturer
Ormco Corporation
1 Event
- Recall of Device Recall Orthos CM Bracket, Orthodontic Metal Bracket,

Manufacturer

Ormco Corporation

Manufacturer Address
Ormco Corporation, 1332 S Lone Hill Ave, Glendora CA 91740
Manufacturer Parent Company (2017)
Danaher Corporation
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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