FDA-Device2018-06-20Class II
Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
Hazard
The implants are mislabeled.
Sold states
US Distribution to the states of : CA, CT, FL, IN, MA, MD, MI, MN, MT, NJ, NV, NY, TX, and VA.
Affected count
72
Manufactured in
154 Middlesex Tpke, N/A, Burlington, MA, United States
Products
Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2162-2018Don't want to check this manually?
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