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Devices
Elements Gutta Percha and Elements RealSeal Cartridges
Model / Serial
Lot Numbers: 06 0959663, 06 0957595, 07 0987641, 08 0992277, 05 0941553, 05 0948690, 06 0955241, 07 0977947, 07 0987642, 08 0992278, 08 0998612
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide and Worldwide to: USA, Canada, Chile, China, Ecuador, Guatemala, Hong Kong, Japan, Malaysia, Singapore, Taiwan and Venezuela
Product Description
Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: 972-1002, 972-1003, 972-2001, 972-2002
Manufacturer
Sybronendo
1 Event
Recall of Elements Gutta Percha and Elements RealSeal Cartridges
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Manufacturer
Sybronendo
Manufacturer Address
Sybronendo, 1717 W Collins Ave, Orange CA 92867
Source
USFDA
Language
English
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