FDA-Device2013-02-13Class II
Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; LSX Files, 30MM, Part Numbers: 835-2031. An engine-driven rotary endodontic instrument used during endodontic procedures for cleaning and shaping the root canal.
Ormco/Sybronendo
Hazard
The length markings on the Lightspeed LSX files were wrong.
Sold states
Worldwide Distribution - USA and the country of Canada.
Affected count
740 units
Manufactured in
1332 S Lone Hill Ave, N/A, Glendora, CA, United States
Products
Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; LSX Files, 30MM, Part Numbers: 835-2031. An engine-driven rotary endodontic instrument used during endodontic procedures for cleaning and shaping the root canal.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0765-2013Don't want to check this manually?
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