# K171553: W&H Assistina Twin

- Pathway: 510(k) (Traditional)
- Applicant: W&H Dentalwerk Buermoos GmbH
- Decided: Dec 8, 2017 after 192 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: 1 generation back to K081811 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081811: CARE3 Plus, Nakanishi, Inc. (2009) Summary page 4.

## Indications for use
Unit for cleaning the spray channels and lubricating the moving parts of dental and surgical handpieces, turbines, air motors and air-driven dental scalers.

Source page: https://510kreport.com/device/K171553
Methodology: https://510kreport.com/methodology