Devices

Device Recall Sealapex Express

Model / Serial
Lot Numbers: 6-1314, 7-1221 and 7-1258.
Product Classification
Dental Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- United States, Australia, Canada, United Arab Emirates, Belgium, Bulgaria, Germany, Spain, France, UK, Greece, Italy, Kuwait, Lebanon, Portugal, Russia, Sweden, Hong Kong, India, Malaysia and Taiwan.
Product Description
Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by SybronEndo, Glendora, CA. || Intended as a root canal filling material that is used in conjunction with gutta percha or silver endodontic points.
Manufacturer
Sybron Dental Specialties
1 Event
- Recall of Device Recall Sealapex Express

Manufacturer

Sybron Dental Specialties

Manufacturer Address
Sybron Dental Specialties, 1717 W Collins Ave, Orange CA 92867-5422
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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