FDA-Device2016-11-02Class II
Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained, screw retained, or overdenture restorations and terminal or inter-mediate abutment support for fixed bridgework
Keystone Dental Inc
Hazard
Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
Sold states
Worldwide distribution - US (Nationwide Distribution to CA, CO, IL, MA, MN, ND, NY, NV, PA, and VA.) and Italy
Affected count
55 units
Manufactured in
154 Middlesex Tpke, Burlington, MA, United States
Products
Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained, screw retained, or overdenture restorations and terminal or inter-mediate abutment support for fixed bridgework
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0299-2017Don't want to check this manually?
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