FDA-Device2015-03-25Class II
Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single Patient Use Fits 13mm Tips. Pack of 400. Metrex Research, Manufacturer. Inner individual packaging of each sleeve: Cure Sleeve by Pinnacle Model 4500
Sybron Dental Specialties
Hazard
Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination.
Sold states
Worldwide distribution. US Nationwide, Canada, Australia, Netherlands, Switzerland, Japan,
Affected count
172
Manufactured in
1717 W Collins Ave, Orange, CA, United States
Products
Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single Patient Use Fits 13mm Tips. Pack of 400. Metrex Research, Manufacturer. Inner individual packaging of each sleeve: Cure Sleeve by Pinnacle Model 4500
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1291-2015Don't want to check this manually?
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