Electronic Apex Locator (Alpha Apex I)

The Electronic Apex Locator (Alpha Apex I) is a microprocessor-controlled dental device that helps dentists determine the correct working length during endodontic (root canal) treatment by measuring the electrical resistance of the tooth and surrounding tissues as a file moves through the root canal. It is intended for use exclusively by qualified dental practitioners.

The device uses dual-frequency AC impedance measurement to detect the apical position with ±0.5mm accuracy. Key differences from the predicate include a larger 5.1-inch TFT color display versus 3.5-inch, a smaller lithium battery (800 mAh) versus larger rechargeable (1000 mAh), different physical dimensions and weight, and a higher-capacity charger (2A output versus 1A). The measurement principle, accuracy, sterilizable components, and safety standards remain identical.

ISO 10993-5, ISO 10993-10, ISO 10993-23 (biocompatibility); IEC 60601-1:2005 +AMD1+AMD2:2020, IEC 80601-2-60:2019 (electrical safety); IEC 60601-1-2:2014+A1:2020, EN 60601-1-2:2015+A1:2021 (EMC); ISO 11737-1:2018, ISO 17665-1:2006, ISO 17665-2:2009 (sterilization); IEC 62133-2 (battery safety).

The device maintains identical intended use, same product code (LQY), same measurement accuracy (±0.5mm), identical sterilization method and biocompatibility standards, and equivalent electrical safety and EMC compliance as the predicate. All performance testing met acceptance criteria. Minor differences in display size, battery capacity, and physical dimensions do not affect safety or function; the larger display and smaller battery represent improvements rather than meaningful changes to the measurement principle or patient contact materials.