# K993526: Synea - LS Low-Speed Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: A-Dec, Inc.
- Decided: Jan 11, 2000 after 85 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.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K051872: MK-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings, and Light Power System, Models:  LS2011 (2005), 2 descendants of its own
- K070155: Integrity Low Speed Dental Air Handpiece and Attachment, Models: Motor Int-E, Motor Int-D and Attachment Int-SNC (2007), 1 descendant of its own
- K053368: Interproximal Reduction System (2006), 1 descendant of its own
- K093971: Dental Handpiece (2010), 0 descendants of its own
- K090548: Contra-Angle Handpiece Komet OS30 (2009), 0 descendants of its own

## Indications for use
A dental low-speed handpiece is designed for removing carious material, cavity and crown preparation, excess filling material, root canal preparations, finishing tooth preparations, restorations and polishing teeth.

Source page: https://510kreport.com/device/K993526
Methodology: https://510kreport.com/methodology