FDA-Device2016-08-10Class II
RePlant¿ Angled Abutment Part Number 6050-52-60
Implant Direct Sybron Manufacturing, LLC
Hazard
Issue with design specification; oversized condition.
Sold states
U.S. distribution to the following; CA, WA, UT, GA, AZ, NE, OR, MI, TX, WI, FL, AL, AR, MO, VA, MA, TN, LA, NC, KS, NY, SC, OK. Foreign distribution to the following; CA, DE, IT, GB, PL, DE, GB, NL, GR, ES, HR, BG.
Affected count
205
Manufactured in
3050 E Hillcrest Dr, Westlake Village, CA, United States
Products
RePlant¿ Angled Abutment Part Number 6050-52-60
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2320-2016Don't want to check this manually?
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