FDA-Device2013-03-27Class II
PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
Keystone Dental Inc
Hazard
Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
Sold states
Worldwide Distribution-USA including DC and the states of CA, FL, IN, MA, MN, NJ, NY, NH, PA, WI, and NY, and the countries of Republic of China, Germany, and France.
Affected count
120 units
Manufactured in
144 Middlesex Tpke, N/A, Burlington, MA, United States
Products
PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0973-2013Don't want to check this manually?
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