# K051661: Implant Handpieces

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Sep 6, 2005 after 76 days
- Product code: EKX (Handpiece, Direct Drive, Ac-Powered)
- 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: 1 generation back to K011061 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011061: Surgical Contra-Angel Handpieces Types WS-56E,WS-75E/KM,WS-92 E/3,Surgical Straight Handpieces Types, S-9, S-10, S-11, W&H Dentalwerk Buermoos GmbH (2001)

## Indications for use
The Sirona Implant 20:1/80:1 Contra-angle handpieces are indicated for surgery, implantology and general dental applications (drilling, grinding etc.).

Source page: https://510kreport.com/device/K051661
Methodology: https://510kreport.com/methodology