# K203615: Dental Scaler and Air Polisher

- Pathway: 510(k) (Traditional)
- Applicant: Guilin Woodpecker Medical Instrument Co., Ltd.
- Decided: Dec 10, 2021 after 365 days
- Product code: ELC (Scaler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 872.4850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K900709 (1990). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110173: Ems Air-Flow Master Piezon, E.M.S Electro Medical Systems S.A (2011) Summary page 5.

## Indications for use
The dental scaler and air polisher, Model PT-A, is intended for use in dental cleaning, periodontal (gum) therapy and polishing. The device polishes the teeth and removes calculus deposits and stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. By attaching the ultrasonic handpiece with different scaling tips, the device could fulfill the following functions: ① Scaling Removal of supragingival calculus; Removal of stains ② Endo Preparation, cleaning and irrigation of root canals; Retrograde preparation of root canals Condensing gutta-percha; Removal of crown, bridges and restorations ③ Restorative Cavity preparation; Luting inlays and onlays; Condensing of amalgams ④ Perio Scaling and root planing; Periodontal treatments By using air polishing handpiece attached with corresponding nozzles, the device could fulfill the following functions • Removing dental plaque • Surface preparation before bonding/cementation of inlays, onlays, crowns and veneers • Tooth surface preparation before placing the composite restoration • Cleaning before sticking orthodontic brackets • Effectively removing plaque for orthodontic patients • Cleaning the implant fixture before loading • Stain removal for shade determination • Removing plaque before fluoride treatment • Removing plaque before whitening procedure

Source page: https://510kreport.com/device/K203615
Methodology: https://510kreport.com/methodology