# K071891: Statis Dental Handpieces

- Pathway: 510(k) (Abbreviated)
- Applicant: Scican, Ltd.
- Decided: Sep 13, 2007 after 66 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K132356: Sanao 200L, Sanao 40 /Sanao 40L, Sanao 10L, Sanao Psi / Sanao Pso, Sanao 40ST (2014), 3 descendants of its own
- K240183: Star E900 Handpiece Series (2024), 0 descendants of its own
- K230106: General Cutting Straight (2023), 0 descendants of its own
- K222518: FX Contra (2022), 0 descendants of its own

## Recalls of this device
- Jan 20, 2023 · Class II · Z-1208-2023: Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button

## Indications for use
The STATIS dental handpieces and drives are intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

Source page: https://510kreport.com/device/K071891
Methodology: https://510kreport.com/methodology