ChecQ (AC100)

The ChecQ (AC100) is a dental implant stability analyzer that uses Resonance Frequency Analysis (RFA) to non-invasively measure implant stability in the oral cavity and maxillofacial region. It comprises a main unit and charging cradle that work with the ChecQPEG attachment to measure stability by analyzing resonant frequencies generated by magnetic field stimulation, displaying results as an Implant Stability Quotient (ISQ) score ranging from 1 to 99.

The ChecQ uses magnetic field stimulation via the ChecQPEG to induce vibrations in magnets, captures the resulting free vibrations as magnetic pulses, processes them through FFT to extract natural frequency, and calculates ISQ values based on that frequency. The device converts voltage pulses from a microcontroller's DAC into magnetic pulses that stimulate the implant attachment.

ANSI AAMI ES 60601-1:2005, IEC 60601-1-2, IEC 60601-1-6, IEC 80601-2-60, IEC 62366-1, IEC 62133-2, ISO 17665-1, IEC 62304, ANSI AAMI ST79, ISO 10993-1/5/10/23, ISO 7405, and ISO 13485:2016.

ChecQ demonstrates substantial equivalence because it has the identical intended use as the predicate devices (Osstell Beacon, K181888 and Tellos ISQ Buddy, K143445) with no significant differences that would adversely affect use. Comparative testing against Osstell Beacon using standardized test jigs confirmed equivalent accuracy in ISQ measurements; ChecQPEG mechanical testing validated dimensional specifications, locking/removal torque, and measurement reliability; and all testing was conducted to recognized international standards establishing functional and performance equivalence.