# K162926: Air-Powered Handpieces and Handpiece Attachments

- Pathway: 510(k) (Traditional)
- Applicant: W&H Dentalwerk Burmoos GmbH
- Decided: Feb 23, 2017 after 127 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: 4 generations back to K983183 (1998). 7 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143704: Advanced Air System, W&H Dentalwerk Buermoos GmbH (2015) Summary page 4.
- K070663: A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97,  a-Dec/W&H Synea Handpiece Attachment, A-Dec, Inc. (2007) Summary page 4.

## Most influential descendants
- 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
- K230895: CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4, (2024), 0 descendants of its own

## Indications for use
The turbine handpiece is intended for the following applications: Removal of decayed materials, cavities and crown preparation, removal of fillings, finishing of tooth and restoration surfaces. The dental handpiece/contra-angle is intended for the following applications: Removal of decayed materials, cavities and crown cement, removal of fillings, finishing and polishing of tooth and restoration surfaces.

Source page: https://510kreport.com/device/K162926
Methodology: https://510kreport.com/methodology