# K952927: Impact Air 45 4-Hole

- Pathway: 510(k) (Traditional)
- Applicant: Palisades Pharmaceutics, Inc.
- Decided: Aug 6, 1996 after 407 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
No predicates in its family tree.
17 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Midwest Quiet Air Handpiece: named in the summary without a submission number

## Most influential descendants
- K112024: TI-Max X450 (2012), 16 descendants of its own
- 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
- K141576: Maxima PRO 45L (2015), 3 descendants of its own

## Indications for use
It is intended for use with all friction-grip bur that conform to I.S.O. and A.D.A.

Source page: https://510kreport.com/device/K952927
Methodology: https://510kreport.com/methodology