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DENTAL HANDPIECE PERFORMANCE CHARACTERISTICS

This article was originally published in The Gray Sheet

Executive Summary

DENTAL HANDPIECE PERFORMANCE CHARACTERISTICS should not be reduced by more than 25% after 250 heat sterilization cycles, John Kuehne, DDS, U.S. Navy, told members of FDA's Dental Products Panel on Dec. 7. Kuehne suggested the limit when asked whether FDA requirements for dental handpiece 510(k)s should include a minimum number of sterilization cycles a handpiece can withstand without showing significant reduction in performance characteristics such as torque and rpm.
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