FDA-Device2023-11-08Class II
Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.
Cosmedent, Inc.
Hazard
Reports were received the elastomer cup material is crumbling.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Colombia, Denmark Ecuador, Estonia, Greece, Hungary, Iran, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Paraguay, Philippines, Spain, Sweden, UAE, and United Kingdom.
Affected count
7,400 packs of 6
Manufactured in
4646 N Ravenswood Ave, N/A, Chicago, IL, United States
Products
Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0211-2024Don't want to check this manually?
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