# K014068: Elcomed, Models SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115

- Pathway: 510(k) (Traditional)
- Applicant: W&H Dentalwerk Buermoos GmbH
- Decided: May 3, 2002 after 144 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. The FDA summary names its predicate without a number.
- (no number) elcomed 100: named in the summary without a submission number

## Indications for use
The Indications are very widespread in the field of oral surgery. A. Implant placement, including 1. preparation of the osfeotomy site 2. bone reconturing, 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 ant teeth bone for e.g. impacted third molars and complicated extractions D. Periodontal surgeries 1. bone recontouring & alveoplasty around living teeth 2. removal of exoslosis E. Endodontic treatment 1. Intracanal preparations using rotating NiTi-files

Source page: https://510kreport.com/device/K014068
Methodology: https://510kreport.com/methodology