FDA-Device2018-04-25Class II
SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.
Southern Implants, (Pty.) Ltd.
Hazard
The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
Sold states
US, South Africa, France
Affected count
49 units
Manufactured in
One Albert Road, Irene, Gauteng, South Africa
Products
SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1386-2018Don't want to check this manually?
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