FDA-Device2018-02-21Class II
Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.
Keystone Dental Inc
Hazard
Abutments are unable to accept the final abutment screw
Sold states
US Nationwide Distribution in the states of ND, NJ & MA
Affected count
20 units
Manufactured in
154 Middlesex Tpke, Burlington, MA, United States
Products
Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw 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-0608-2018Don't want to check this manually?
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