FDA-Device2016-01-06Class II

Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.

Biomet 3i, LLC
Hazard

Images contained within radiographic transparency ART 1036 are undersized.

Sold states
Worldwide Distribution - US Distribution including Puerto Rico., and to the states of : CA, CO, FL, IL, MA, MI, MO, NY, OH, SC, TX, VA, WI, WV and Hawaii., and to the countries of : Australia, Germany, France, Greece, Northern Mariana Islands, Taiwan and Uruguay.
Affected count
686
Manufactured in
4555 Riverside Dr, N/A, Palm Beach Gardens, FL, United States
Products
Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0564-2016

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