Integrated Endo System (Meet Endo-II)

The Integrated Endo System (Meet Endo-II) is a dental control unit that combines multiple handpieces for root canal treatment: an endo motor for canal cleaning, an obturation unit for filling and pressurizing the canal, an electronic apex locator for measuring working length, and an ultrasonic handpiece for canal preparation. It is intended for use by trained dental professionals in clinical settings for patients requiring root canal therapy.

The subject device uses a 14.4V Li-Ion battery (69.12Wh) versus the predicate's 7.2V (48Wh), and operates at 45±10kHz ultrasonic vibration compared to the predicate's 27-33kHz. The main unit features wireless charging and five connecting sockets; the predicate has a microSD slot and wireless footswitch. Both achieve equivalent apex locator accuracy (±0.5mm) and use the same ultrasonic module technology. Minor differences exist in endodontic motor torque range specifications, activation method, and component materials.

Biocompatibility per ISO 10993-1 (cytotoxicity, sensitization, irritation); electrical safety per IEC 60601-1 and IEC 80601-2-60; electromagnetic compatibility per IEC 60601-1-2 and IEC TR 60601-4-2; wireless coexistence per ANSI/USEMCSC C63.27 and FCC CFR 47 Part 15; reprocessing validation per FDA guidance; software verification per IEC 62304; usability testing per IEC 62336-1; coupling per ISO 3964 and ISO 14457.

Both devices share identical indications for use, regulatory classification (Class II), and intended users/settings. The subject device performs the same functions (motor-driven canal preparation, obturation, apex location, ultrasonic cleaning) with the same mode of action as the predicate EndoPilot2. Minor technological differences—battery capacity, vibration frequency, activation method, and component design—were evaluated through performance testing and do not raise new questions because they do not alter the fundamental therapeutic function or clinical safety profile compared to the legally marketed predicate device.