FDA-Device2020-10-14Class II
PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.
Ultradent Products, Inc.
Hazard
Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
Sold states
Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, KS, IN, LA, MA, MD, ME, MI, MT, NC, NJ, NM, NY, NV, OH, OK, PA, SC, TN, TX, UT, VT, WA, and WI. The countries of Australia, Germany Japan and Mongolia.
Affected count
412 syringes (206 kits)
Manufactured in
505 W 10200 S, N/A, South Jordan, UT, United States
Products
PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0053-2021Don't want to check this manually?
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