# K972889: Elcomed 100 Types 9925 (W&H- and Innova-Version) and 9927 (Astra-Version), Elcomed 200 Type 9926 (W&H-Version)

- Pathway: 510(k) (Traditional)
- Applicant: W & H Dentalwerk
- Decided: Jan 22, 1998 after 170 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Indications are very widespread in the field of oral surgery ranging from A. Implant placement, including 1. preparation of the osteotomy site 2. bone recontouring, osteoplasty B. Bone grafting 1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.) 2. harvesting autogen living bone 3. sinus elevation & grafting of alveolar sockets C. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions D. Periodontal surgeries 1. bone recontouring & alveoplasty around living teeth 2. removal of exostosis E. Endodontic treatment Intracanal preparations using rotating NiTi-files.

Source page: https://510kreport.com/device/K972889
Methodology: https://510kreport.com/methodology