# K161957: W&H Implantmed SI-1015 incl. Accessories

- Pathway: 510(k) (Traditional)
- Applicant: W&H Dentalwerk Burmoos GmbH
- Decided: Nov 23, 2016 after 128 days
- Product code: EBW (Controller, Foot, Handpiece And Cord)
- 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: 2 generations back to K002469 (2001). 2 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052741: Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl. Accessories, W&H Dentalwerk Buermoos GmbH (2006) Summary page 4.

## Most influential descendants
- K173905: Surgic Pro, Surgic Pro+ (2018), 5 descendants of its own
- K201192: Impla-NX (Model: ISE-270M) (2021), 1 descendant of its own
- K253776: Implantmed Plus II & Piezomed Plus II Module (2026), 0 descendants of its own
- K231562: ELEC ENGINE (Model: ISE-170L) (2025), 0 descendants of its own
- K233117: Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) (2024), 0 descendants of its own

## Indications for use
Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.

Source page: https://510kreport.com/device/K161957
Methodology: https://510kreport.com/methodology