# K780038: Dental Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Lares Manufacturing Co., Inc.
- Decided: Jan 20, 1978 after 11 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.
21 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K972376: Impact  Air 45 Handpiece for Periodontal Use (1997), 18 descendants of its own
- K101717: Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam 45; Dexor 45; Karam 4H Coupling (2010), 17 descendants of its own
- K112024: TI-Max X450 (2012), 16 descendants of its own
- K972375: Impact Air 45 Handpiece for Endodontic Use (1997), 10 descendants of its own
- K130455: 430 SWL 45 and 430 SW 45 High-Speed Handpieces (2013), 9 descendants of its own

Source page: https://510kreport.com/device/K780038
Methodology: https://510kreport.com/methodology