Synea Fusion Handpieces (Intensiv & Profin)

The Synea Fusion Handpieces are reciprocating/oscillating dental contra-angle handpieces powered by air motors or electric micromotors. They are used for tooth preparation, removing excess filling materials and cements, finishing and polishing in interdental and subgingival regions, plaque removal, and interproximal reduction in orthodontics. Two product lines are included: Profin handpieces (WG-67 models) compatible with Dentatus tips, and Intensiv handpieces (WG-68 and WG-69 models) compatible with Intensiv SA tips.

The devices share identical design principles, ISO 3964 motor connections, and sterilization requirements as the predicate. Most models match the predicate in dimensions (94 × Ø 20.2 mm, head 8.2 mm) and drive speed (20,000 RPM), though WG-68 and WG-69 models have slightly different head sizes (10 mm) and gearing ratios (1:1 and 2:1 respectively) driven by tip manufacturer specifications. All use identical materials, spray systems, and autoclave sterilization protocols.

ISO 14457:2017 (handpieces and motors), ISO 10993-1:2009 and ISO 7405:2008 (biocompatibility), ISO 17664:2017 and ANSI/AAMI ST79:2010 (reprocessing and sterilization), ISO 17665-1:2006 (sterilization process validation), and ISO 14971:2007 (risk management). Additional internal testing included material chemical resistance, lifetime tests, torque and functionality tests, and packaging stability validation.

The new devices are substantially equivalent because they are manufactured by the same company using identical materials and operating principles as the predicate device K082827, maintain the same regulatory class, indications for use, and general design architecture. Minor differences in drive speed and gearing ratios for WG-68 and WG-69 models are necessitated by different tip manufacturer specifications but do not raise new safety or effectiveness concerns. Non-clinical testing demonstrates equivalent performance, and biocompatibility and reprocessing validations confirm these differences pose no additional risk.