# K221548: Dental Air Polishing Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Guilin Woodpecker Medical Instrument Co., Ltd.
- Decided: Sep 28, 2022 after 124 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: 7 generations back to K900709 (1990). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151912: AIR-FLOW handy 3.0 PLUS, E.M.S Electro Medical Systems S.A (2016) Summary page 4.

## Indications for use
The Dental Air Polishing Handpiece, AP-H Plus is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching, fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances. The Dental Air Polishing Handpiece, AP-H Plus is intended for patients suffering from periodontal disease. The Dental Air Polishing Handpiece, AP-H Plus is indicated for the non-surgical removal of subgingival plaque in pockets up to 4 mm after initial periodontal treatment.

Source page: https://510kreport.com/device/K221548
Methodology: https://510kreport.com/methodology