# K992648: Rotary Master

- Pathway: 510(k) (Traditional)
- Applicant: J. Morita USA, Inc.
- Decided: Jan 31, 2000 after 178 days
- Product code: EBW (Controller, Foot, Handpiece And Cord)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ROTARY MASTER device is a control unit that drives a dc electric micromotor that can be turned on or off by a foot switch. It is intended for use in general dental applications such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay, or filling, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle, or contra-angle ISO E-type attachment of equal speed, speed increasing or decreasing sheath. The micromotor speed is adjustable by the control knob on the front face of the control unit from 2,000 to 30,000 rpm. Special Note: Because the electric motor and its cord are not autoclavable, an adequate covering by plastic sleeving as commonly used in dentistry for infection control should be used during treatment.

Source page: https://510kreport.com/device/K992648
Methodology: https://510kreport.com/methodology