# K072989: Axis System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl., Inc.
- Decided: Jan 28, 2008 after 97 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: 2 generations back to K983183 (1998). 4 ancestors in all.
8 later devices descend from it; 1 cites 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)
- K003518: Rapidd Highspeed Dental Handpiece, Dentsply Intl. (2001) Summary page 1.
- K031145: Estylus Electric Motor System, Dentsply Intl. (2003) Summary page 1.

## Most influential descendants
- K143704: Advanced Air System (2015), 7 descendants of its own
- 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

## Indications for use
Axis System is an air-powered dental handpiece system indicated for use in general dentistry.

Source page: https://510kreport.com/device/K072989
Methodology: https://510kreport.com/methodology