FDA-Device2025-02-12Class II
Temporary Titanium Abutments
DDS Lab
Hazard
Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fracture, which may risk loosening of the affixed restoration; fragments could also injure oral mucosa, and could be aspirated.
Sold states
US Nationwide distribution including in the states of FL, TN, TX, MA, NH, CT, ME, WA, IN, CA, PA, NV, MO, IL, AK, MN, VT, OH, MI, VA, WI, AL, AZ, KY, MT, OK, CO, LA, GA, NY, WV, NC, NJ, MD, OR, DE, SC, ID, KS, IA, AR, NM, HI, DC, MS, NE, RI, UT.
Affected count
11,259
Manufactured in
5440 Beaumont Center Blvd Ste 400, Tampa, FL, United States
Products
Temporary Titanium Abutments
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1111-2025Don't want to check this manually?
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