FDA-Device2018-08-01Class II
ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Implant Direct Sybron Manufacturing, LLC
Hazard
The main vial label lists the incorrect part number, but the cap label is correct.
Sold states
Distribution was made to AZ, CA, CO, CT, FL, ID, IL, NC, NJ, NV, NY, PA, TX, UT, VA, and WA. There was no government/military distribution. Foreign distribution was made to Switzerland, Germany, Lithuania, and Spain.
Affected count
124 units
Manufactured in
3050 E Hillcrest Dr, N/A, Thousand Oaks, CA, United States
Products
ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2551-2018Don't want to check this manually?
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