FDA-Device2019-11-20Class II
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
Implant Direct Sybron Manufacturing, LLC
Hazard
packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
Sold states
US distribution in the states of: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO,
Affected count
53 implants
Manufactured in
3050 E Hillcrest Dr, N/A, Westlake Village, CA, United States
Products
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0363-2020Don't want to check this manually?
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