# K143704: Advanced Air System

- Pathway: 510(k) (Traditional)
- Applicant: W&H Dentalwerk Buermoos GmbH
- Decided: Nov 23, 2015 after 329 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: 3 generations back to K983183 (1998). 5 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072989: Axis System, Dentsply Intl., Inc. (2008) Summary page 4.

## Most influential descendants
- K162926: Air-Powered Handpieces and Handpiece Attachments (2017), 6 descendants of its own
- K181858: Electric Handpiece Motor (2019), 4 descendants of its own
- K213022: CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED (2022), 1 descendant of its own
- K233288: NLZ Built-In Motor System (2024), 0 descendants of its own
- K233308: Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) (2024), 0 descendants of its own

## Indications for use
Pneumatic drive system for dental handpieces and dental air motors, which is intended to be used in general dental applications such as: removal of decayed materials, cavities and crown preparations, removal of filings, finishing of tooth and restauration surfaces, polishing, prophylaxis and endodontics.

Source page: https://510kreport.com/device/K143704
Methodology: https://510kreport.com/methodology