# K002469: Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V)

- Pathway: 510(k) (Traditional)
- Applicant: W&H Dentalwerk Buermoos GmbH
- Decided: Feb 7, 2001 after 180 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
No predicates in its family tree.
28 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K052741: Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl. Accessories (2006), 27 descendants of its own
- K161957: W&H Implantmed SI-1015 incl. Accessories (2016), 8 descendants of its own
- K173905: Surgic Pro, Surgic Pro+ (2018), 5 descendants of its own
- K123695: Traus SIP10 (2012), 4 descendants of its own
- K092214: Chiropro L System (2009), 4 descendants of its own

Source page: https://510kreport.com/device/K002469
Methodology: https://510kreport.com/methodology