# K101717: Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam 45; Dexor 45; Karam 4H Coupling

- Pathway: 510(k) (Traditional)
- Applicant: Aerobine, Inc.
- Decided: Aug 20, 2010 after 63 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: 4 generations back to K935676 (1995). 9 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062740: Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MU, Jindell Medical Instruments Co., Ltd. (2006) Summary page 1.
- K972376: Impact  Air 45 Handpiece for Periodontal Use, Glenwood, LLC (1997) Summary page 1.

## 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
Karam STD, Karam Mini, Karam ECN, AeroBreeze STD, and AeroBreeze Mini models are air-powered highspeed dental handpieces with intended use of preparing dental cavities for restorations, such as fillings, reducing hard tooth structure, and cleaning teeth. Karam STD, Karam Mini, AeroBreeze STD, and AeroBreeze Mini can be used with either Type B (Karam 4B3) or Type A (Karanm 2A) coupling. Karam ECN model connects directly to either Type A or Type B hose connectors and does not require a coupling. Karam45 and Dexor45 are air-powered highspeed dental handpieces with intended use of being a surgical tool for impacted third molar removal and periodontal procedures for which a conventional handpiece would be used. Both models can be used with either Type B (Karam 4B3) or Type A (Karam 2A) coupling.

Source page: https://510kreport.com/device/K101717
Methodology: https://510kreport.com/methodology