# K170261: Premium Plus Prophy Air Motor

- Pathway: 510(k) (Abbreviated)
- Applicant: Premium Plus International Limited
- Decided: Oct 19, 2017 after 265 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
Longest line of descent: 2 generations back to K896877 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070869: Prophy Star 3 Hygiene Handpiece, Model 264422, Dentalez, Inc. (2007) Summary page 4.

## Indications for use
The Premium Plus Prophy Air Motor is intended to be used with a disposable prophy angle and polishing paste by a trained dental clinician to perform dental prophylaxis.

Source page: https://510kreport.com/device/K170261
Methodology: https://510kreport.com/methodology