FDA-Device2021-05-05Class II
Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. Model number/Catalog number: L741
Coltene Whaledent Inc
Hazard
The incorrect dental pins were packaged and subsequently distributed.
Sold states
Worldwide distribution - US Nationwide distribution in the states of NJ, IN, NC, IL. GA, CA, NY, PA and the countries of Canada, Venezuela.
Affected count
65 packs of 20 pins
Manufactured in
235 Ascot Pkwy, N/A, Cuyahoga Falls, OH, United States
Products
Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. Model number/Catalog number: L741
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1494-2021Don't want to check this manually?
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