FDA-Device2023-09-20Class II
Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
Keystone Industries
Hazard
The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. The contents of the Kit and the IFU enclosed with the kit were correctly labeled as Hard Line materials
Sold states
US Nationwide distribution in the states of IL, PA, FL NV, TX.
Affected count
240 units
Manufactured in
480 S Democrat Rd, Gibbstown, NJ, United States
Products
Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2580-2023Don't want to check this manually?
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