FDA-Device2022-08-31Class II
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Nobel Biocare
Hazard
Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
Sold states
U.S Nationwide.: AZ, CA, CT, FL, HI, NC, NY, OR, PA, TX, UT, and WI O.U.S.: Austria, Belgium, Canada, Germany, Spain, France, United Kingdom, Hungary, Iceland, Italy, Netherlands, Norway, Portugal, and Sweden
Affected count
347 devices
Manufactured in
Vastra Hamngatan 1, Goteborg, Sweden
Products
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1565-2022Don't want to check this manually?
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