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Sterilization Archived Through 2012
 FAQ - Sterilization - Archived Through 2012

 

 

What is the acceptability on glass bead sterilizers? 

Hot salt/glass bead sterilizers are not acceptable for the sterilization of items between patients. The endodontic dry heat sterilizer (glass bead sterilizer) is no longer cleared by the Food and Drug Administration (FDA). The FDA Dental Device Classification Panel has stated that the glass bead sterilizer presents "a potential unreasonable risk of illness or injury to the patient because the device may fail to sterilize dental instruments adequately."
References:

(1) Food and Drug Administration. Revision 11/3/99 - import alert 89-11, detention without physical examination of class III devices without PMAs or PDPs. Available at http://www.fda.gov/ora/fiars/ora_import_ia8911.html
(2) American Electrology Association Infection Control Standards for the Practice of Electrology. Available at  http://www.fda.gov/ohrms/dockets/ac/02/briefing/3839b1_
I8_aea.doc
 

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