# K972375: Impact Air 45 Handpiece for Endodontic Use

- Pathway: 510(k) (Traditional)
- Applicant: Glenwood, LLC
- Decided: Sep 10, 1997 after 77 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 K760794 (1976). 4 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K760794: Fiber Optics High Speed Handpiece, Midwest (1976) Summary page 1.
- K863677: Tradition High Speed Handpiece, Midwest (1986) Summary page 1.
- K780038: Dental Handpiece, Lares Manufacturing Co., Inc. (1978) Summary page 1.
- K912786: W-H Topair Dental Handpiece, Sabra-The Dental Products Group (1991) Summary page 1.

## Most influential descendants
- K130455: 430 SWL 45 and 430 SW 45 High-Speed Handpieces (2013), 9 descendants of its own
- K152146: High Speed Handpieces and Accessories (2015), 8 descendants of its own
- K170229: Dental High-speed Turbine Handpiece (2017), 4 descendants of its own
- K181691: High-speed air turbine handpiece / Low-speed air turbine handpiece (2020), 2 descendants of its own
- K220179: High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors (2023), 1 descendant of its own

## Indications for use
The Impact Air 45 Handpiece for Endodontic Use is an air-powered dental handpiece intended for use in apicoectomy (root canal drainage) and other endodontic procedures for which a conventional handpiece would be used.

Source page: https://510kreport.com/device/K972375
Methodology: https://510kreport.com/methodology