GBT Machine Airflow Prophylaxis Master

The GBT Machine AIRFLOW Prophylaxis Master is a dental device combining ultrasonic scaling and air-polishing functions in a single unit. It is used for removing calculus and stains from teeth, periodontal pocket lavage, scaling and root planing, and cleaning/polishing teeth using water, air, and dental powders. It is also indicated for non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The GBT Machine shares the same fundamental piezoelectric ultrasonic scaling technology and air-polishing function as the predicate AIRFLOW Prophylaxis Master. Key improvements include an updated ultrasonic generator module with improved performance (same frequency range and power), electronic water flow control, improved water bottle irrigation system, new cart design, simplified user settings, RFID-based handpiece recognition, and Wi-Fi/LTE connectivity for data transmission and remote diagnostics. These connectivity features do not impact treatment functionality or raise new safety or effectiveness concerns.

Electrical safety testing per IEC 60601-1:2005 + A1:2012 + A2:2020 and IEC 80601-2-60:2019; electromagnetic compatibility testing per IEC 60601-1-2:2014+AMD1:2020; wireless coexistence testing per IEEE/ANSI C63.27-2021; performance testing per ISO 18397:2016, ISO 7494-1:2018, and ISO 7494-2:2022; cybersecurity testing including static analyses and penetration testing; and bench and software testing to internal company protocols.

The GBT Machine AIRFLOW Prophylaxis Master is substantially equivalent to the predicate AIRFLOW Prophylaxis Master (K190124) because it maintains the same fundamental technology, intended use, and indications for use while incorporating design modifications that do not alter performance, reliability, or safety. The modifications (improved generator, connectivity features, ergonomic enhancements) are intended-use preserving and do not raise new questions of safety or effectiveness.