Microdent Sterilization Cassette

The Microdent Sterilization Cassette is a reusable container system designed to organize, protect, and store dental surgical drills and tools during steam sterilization. It facilitates sterilization by allowing steam penetration and air removal. When used with FDA-cleared sterilization accessories (wrap, biological and chemical indicators) in an FDA-cleared sterilizer, sterility of enclosed instruments is maintained until use. The device is sterilized in a pre-vacuum steam sterilizer at 270°F/132°C for 4 minutes with 20 minutes drying time.

The Microdent cassettes consist of plastic bases and covers with evenly distributed perforations to enable steam penetration. Available in eight models ranging from 220g to 509g with dimensions from 143×79×23mm to 184×136×31mm. All models feature silicone mats and locking tabs or guides. The design includes modular insert trays and covers similar to the predicate PolyVac device, with the primary differences being dimensions and specific design features rather than fundamental technology.

ISO 17665-2:2009 and ANSI/AAMI/ISO 17665-1:2006/(R)2013 for sterilization cycle validation; ANSI/AAMI ST77:2013 for steam sterilization parameters; AAMI TIR30:2011 for manual and automated cleaning validation; internal test methods for drying validation and reprocessing durability (100 cycles).

Microdent cassettes are substantially equivalent to the PolyVac predicate because both devices share the same FDA classification (Class II, product code KCT), intended use (organizing and facilitating sterilization with steam penetration and air removal), fundamental design (base, modular trays, covers with perforations and silicone mats), sterilization parameters (pre-vacuum steam at 132°C for 4 minutes), and reusability. Both require use with FDA-cleared sterilization wraps. Non-clinical testing demonstrates equivalent or superior performance in sterilization validation, cleaning, and reprocessing durability. The only material differences are in dimensions and specific design configurations, which do not affect safety or effectiveness.