K5 Cart, K5 Mount, K5 Swing

The K5 Cart, K5 Mount, and K5 Swing are AC-powered dental operative units with accessories designed to supply power and serve as a base for dental devices and accessories. These devices include a treatment chair, dentist and assistant elements, dental light, and various controls, intended for use by dentists and dental assistants to assist in dental treatment by adjusting patient position, operating instruments, and supplying water to the oral cavity in clinical environments.

The proposed devices are substantially similar to the predicate K5 (K233805) in design and function. Minor differences include: three model types (Mount, Cart, Swing versus Mount and Cart for predicate); maximum air pressure specification of 550–600 kPa versus 550–750 kPa for predicate; chair height range of 450–850 mm versus 440–840 mm; and headrest range of −90° to 75° versus −90° to 70°. Main components, syringe type, control systems, water systems, electrical safety, and electromagnetic compatibility are identical.

Electrical safety and electromagnetic compatibility verified per IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, and IEC 60601-1-6. Performance testing per ISO 7494-1 and ISO 7494-2. Software verification and validation per IEC 62304 and FDA Guidance on Device Software Functions.

The proposed devices function identically to the predicate in intended use and core operation. Although there are minor dimensional and specification differences (air pressure limits, chair height, headrest range, and three model types versus two), these do not raise new safety or effectiveness concerns because: (1) all differences are minor engineering variations that do not alter the fundamental design or method of operation; (2) performance testing against the same consensus standards (ISO 7494-1/2) demonstrates equivalent performance; (3) electrical safety and EMC compliance use identical standards; and (4) the software is functionally identical except for user interface updates, verified under IEC 62304.