# K982050: Model MS-2 Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Sep 2, 1998 after 83 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- 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. The FDA summary names its predicate without a number.
- (no number) Prophyflex 2, Model 2012: named in the summary without a submission number

## Indications for use
An air-powered handpiece intended for use in removing dental plague and stains from teeth by projecting a stream of air, water and sodium bicarbonate onto tooth surfaces. Its use is contraindicated on patients with chronic respiratory disease, renal deficiencies or suffering chronic diarrhea and those on salt-free or salt-limited diet regimens.

Source page: https://510kreport.com/device/K982050
Methodology: https://510kreport.com/methodology