Devices

Device Recall Sealapex Xpress

Model / Serial
lot # 5-1310
Product Classification
Dental Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Mexico, Belgium, Denmark, Germany, Great Britain, and Sweden.
Product Description
Sealapex Xpress, Part No. 33639 || The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth.
Manufacturer
Ormco/Sybronendo
1 Event
- Recall of Device Recall Sealapex Xpress

Manufacturer

Ormco/Sybronendo

Manufacturer Address
Ormco/Sybronendo, 1332 S Lone Hill Ave, Glendora CA 91740-5339
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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