# K100731: Bosworth Air Polisher

- Pathway: 510(k) (Traditional)
- Applicant: Harry J. Bosworth Co.
- Decided: Dec 3, 2010 after 263 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 K900709 (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)
- K073284: Air-Flow Master Standard, (Ems Sa) Electro Medical Systems (2007) Summary page 1.

## Indications for use
The Bosworth Air Polisher is a dental handpiece used for cleaning and polishing teeth. It projects a spray of water, air, and powder onto the tooth surface. The Bosworth air Polisher is designed to be used by a Dental Professional. It is a prescription device The packaging contains the folowing statement. "Caution: Federal law restricts this device to sale by or on the order of a Dentist.

Source page: https://510kreport.com/device/K100731
Methodology: https://510kreport.com/methodology