Klockner Kits

The KLOCKNER KITS are reusable rigid sterilization trays designed to organize and protect dental surgical instruments during steam sterilization. The kits consist of a perforated polysulfone base, lid, and inner tray with silicone instrument holders. They must be enclosed in an FDA-cleared sterilization wrap and sterilized using dynamic air removal steam at 134°C for 4 minutes followed by 16 minutes of drying time. The kits are available in six configurations ranging from 820 grams to 240 grams in combined weight with instruments.

The subject device offers two tray sizes in six configurations compared to the predicate's single size and configuration. Both devices use perforated polysulfone or similar polymer construction compatible with moist heat sterilization. The subject device has vent-to-volume ratios of 0.504 in²/in³ for most configurations and 0.181 in²/in³ for the smallest, comparable to the predicate's 0.181 in²/in³. Both require FDA-cleared sterilization wraps and support reusable service life, though the subject device is validated for 20 cycles versus the predicate's 101 cycles.

ISO 17665-1:2006 and ISO 17665-2:2009 (sterilization validation); AAMI ST8:2013 (manual cleaning validation); AAMI TIR12:2020 (drying time and life cycle testing); ISO 10993-5:2009 and ISO 10993-12:2012 (biocompatibility/cytotoxicity); FDA Guidance on Reprocessing Medical Devices (2015).

The subject device achieves substantial equivalence because it shares the same intended use, product code (KCT), and regulatory classification as the predicate K173642. Both are rigid, reusable sterilization containers requiring FDA-cleared wrap and moist heat steam sterilization at 134°C. Despite the subject device offering multiple size and configuration options versus the predicate's single configuration, nonclinical testing demonstrates equivalent or superior performance: sterilization validation across four configurations achieved a minimum SAL of 10⁻⁶, life-cycle testing confirmed 20 usable cycles with a 2X safety margin, and biocompatibility testing showed no cytotoxicity. The larger number of configurations and similar vent-to-volume ratios are adequately addressed by the sterilization validation study.