Enbio PRO

The Enbio PRO is a table-top steam sterilizer that uses pressurized steam and pre-vacuum technology to sterilize dental and medical instruments. It features three sterilization programs operating at 121°C or 134°C with varying exposure and drying times, and has a 5.3-liter chamber capacity with a maximum load of 1.6 kg per cycle.

The Enbio PRO has a larger sterilization chamber (5.3 L vs. 2.7 L) and greater maximum load capacity (1.6 kg vs. 0.5 kg) than the predicate Enbio S. Chamber dimensions are 300 x 200 x 90 mm compared to 292 x 192 x 45 mm for the predicate. Sterilization cycle parameters (temperature, exposure time) are identical; drying times differ slightly but remain within standard values.

AAMI ANSI ST55:2016 for performance and sterilization efficacy; IEC 61010-1 and IEC 61010-2-040 for electrical safety; IEC 60601-1-2 for electromagnetic compatibility. Testing included vacuum tests, Bowie & Dick tests, full and half cycle studies, and biological performance studies demonstrating 10⁻⁶ sterility assurance level.

The Enbio PRO is substantially equivalent to the predicate Enbio S because both are air-removal pre-vacuum table-top steam sterilizers with identical intended use, same sterilization cycles and temperatures, and same regulatory classification. Although the PRO has a larger chamber and load capacity with minor variations in drying times, these differences are within standard sterilization parameters and performance has been validated to the same standards as the predicate.