# K053368: Interproximal Reduction System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International
- Decided: Mar 29, 2006 after 114 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 K944711 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993526: Synea - LS Low-Speed Handpiece, A-Dec, Inc. (2000) Summary page 1.
- K944711: W&H Air Motor A25, A-Dec, Inc. (1995) Summary page 1.

## Most influential descendants
- K090548: Contra-Angle Handpiece Komet OS30 (2009), 0 descendants of its own

## Indications for use
The Interproximal Reduction System is indicated as a method for achieving interproximal reduction of teeth.

Source page: https://510kreport.com/device/K053368
Methodology: https://510kreport.com/methodology