# K130455: 430 SWL 45 and 430 SW 45 High-Speed Handpieces

- Pathway: 510(k) (Traditional)
- Applicant: Dentalez Group, Stardental Division
- Decided: Sep 25, 2013 after 215 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: 6 generations back to K935676 (1995). 14 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960719: Star Dental 430 Series High Speed Handpiece, Dentalez Group (1996) Summary page 1.
- K112024: TI-Max X450, Nakanishi, Inc. (2012) Summary page 1.
- K972375: Impact Air 45 Handpiece for Endodontic Use, Glenwood, LLC (1997) Summary page 1.

## Most influential descendants
- 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
- K251389: High speed air turbine handpiece (2026), 0 descendants of its own

## Indications for use
The 430 SWL 45 and 430 SW 45 air-powered high speed handpieces are used by trained dental professionals for the removal of impacted third molars as well as endodontic and periodontal procedures for which a conventional handpiece would be used.

Source page: https://510kreport.com/device/K130455
Methodology: https://510kreport.com/methodology
