Disposable Prophy Angle (3399-60, 3399-090, 3399-105)

The Disposable Prophy Angle is a dental rotational device consisting of a prophy cup, plastic body, gear, and shaft that attaches to a low-speed dental handpiece. It is used by professional dentists and dental hygienists for polishing and cleaning tooth surfaces and is intended for single use and disposal after each patient.

The subject device has the same indications for use, target uses, design, operation speed, operation principle, and materials as the predicate device. Both are single-use, non-cytotoxic, non-sensitizing, and non-irritating devices with only minor differences that do not constitute new intended uses or raise different safety and effectiveness issues.

ANSI/ADA Specification No. 85, Part 1 Disposable Prophy Angle was used for non-clinical testing to establish substantial equivalence to the predicate device.

The proposed device is substantially equivalent to the predicate Premium Plus Disposable Prophy Angle (K100854) because it shares identical indications for use, design, operation principle, and materials. Non-clinical testing demonstrated the subject device is as safe, effective, and performs as well as or better than the predicate device, with only minor differences that do not affect safety or effectiveness.