# K992011: Synea-HS High Speed-Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: A-Dec, Inc.
- Decided: Sep 10, 1999 after 87 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.
12 later devices descend from it; 1 cites it directly.
0 of 13 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
- K043498: Twin Power Turbine High Speed Air Turbine Dental Handpiece (2005), 11 descendants of its own
- K061701: High Speed Air Turbine Handpieces, Par-4HEX/4HX Series (Twin Power Turbine 4H) (2006), 7 descendants of its own
- K130560: Mastertorque Lux 8900 L (2013), 5 descendants of its own
- K141886: MDK Handpieces (2015), 3 descendants of its own
- K131319: T1/T2/T3 Turbine Family (2014), 2 descendants of its own

## Indications for use
A dental high-speed handpiece is designed for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

Source page: https://510kreport.com/device/K992011
Methodology: https://510kreport.com/methodology