Rextar Pro

The Rextar Pro is a portable, battery-powered extraoral dental X-ray system designed for use by trained dentists and dental technicians to produce diagnostic X-ray images of adult patients. It features a high-frequency 70 kV/2mA X-ray generator with a handheld design, rechargeable battery, and advanced shielding using 99.9% pure lead to minimize operator radiation exposure.

Compared to the predicate Rextar X, the Rextar Pro has a lower power source (12.6 VDC 1A vs. 19 VDC 3.16A), tighter kV and exposure time tolerances (±5% vs. ±7% and ±10%), reduced inherent filtration (0.5mm AL Eq. vs. 1.0mm AL Eq.), increased added filtration (1.0mm AL vs. 0.5mm AL), a different LCD display, and smaller physical dimensions and weight (140×163.5×140mm, 1.5kg vs. 146×155×139mm, 1.9kg). The subject device is restricted to adult patients only, whereas the predicate is indicated for both pediatric and adult patients.

IEC 60601-2-65:2021 (dental intra-oral X-ray equipment), IEC 60601-1:2020 (general medical electrical equipment safety), IEC 60601-1-2:2014 with Amendment 1:2021 (electromagnetic disturbances), and FDA software guidance on premarket submissions for device software functions.

The device has the same indications for use and performs the same function as the predicate within its specified adult-only patient population. All technological differences (power source, tolerances, filtration, dimensions, weight) are design modifications to accommodate a smaller, more portable form factor and do not introduce new safety or effectiveness concerns. Leakage radiation testing demonstrates the device's radiation exposure to operators is well below NCRP occupational limits. Testing per applicable IEC standards shows compliance with the same safety and performance requirements as the predicate, confirming no new issues of safety and effectiveness are raised.