# K060287: Drilltech, Ism, Implantunit, Zimmer Surgical Motor System

- Pathway: 510(k) (Traditional)
- Applicant: W&H Dentalwerk Buermoos GmbH
- Decided: May 3, 2006 after 86 days
- Product code: EBW (Controller, Foot, Handpiece And Cord)
- 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
Longest line of descent: 2 generations back to K002469 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002469: Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V), W&H Dentalwerk Buermoos GmbH (2001) Summary page 1.
- K052741: Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl. Accessories, W&H Dentalwerk Buermoos GmbH (2006) Summary page 1.

## Recalls of this device
- Dec 21, 2017 · Class II · Z-1351-2018: During continuous postmarket surveillance activities, we have noticed a potential malfunction of individual foot controls of the type S-N1/S-N2. In case the error occurs, the foot control might not sw

## Indications for use
Mechanical drive unit with coolant supply for transmission instruments with coupling system according to ISO 3964. The equipment is a drive unit for use in dental surgery, implantology and maxillo-facial surgery for treatment of dental hard tissue.

Source page: https://510kreport.com/device/K060287
Methodology: https://510kreport.com/methodology