Disposable Prophy Angle

The Disposable Prophy Angle (DPA) is a single-use dental handpiece attachment consisting of a plastic housing with an internal drive shaft and spindle aligned at 90 degrees. It features a rubber prophy cup on the spindle tip for polishing and cleaning teeth, with food-grade grease as lubricant between the shaft and spindle. Available in soft cup and firm cup formats.

The device has identical design, principle of operation, and energy source as the predicate device. The cup material contacting the patient is the same as the predicate. All materials have passed biocompatibility testing with comparable results to the predicate device in performance testing.

Temperature rise and vibration testing were performed on all models (soft and firm cup variants) per ANSI ADA Specification No. 85, Part I Disposable Prophy Angles, section 5.5, which is identified as the most relevant FDA-recognized consensus standard for this device type.

The device raises no new questions of safety and effectiveness compared to predicates because it uses the same design, operational principle, energy source, and patient-contact cup material as legally marketed predicate devices. Biocompatibility and performance testing demonstrate equivalent safety profiles, and testing per the applicable ANSI consensus standard confirms equivalent performance characteristics.