FDA-Device2019-02-13Class II
Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY.
Handpiece Headquarters
Hazard
Tip of the curing light was too hot causing a heat sensation in the patients.
Sold states
Worldwide distribution including US nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, and WV, and to Guam. There was also military/government distribution, and countries of Johannesburg, Panama, Suriname, and Trinidad.
Affected count
252 curing lights (rec'd by recalling firm; 142 were further dist)
Manufactured in
620 S Placentia Ave, Placentia, CA, United States
Products
Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0797-2019Don't want to check this manually?
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