# K090548: Contra-Angle Handpiece Komet OS30

- Pathway: 510(k) (Abbreviated)
- Applicant: W&H Dentalwerk Buermoos GmbH
- Decided: Jun 30, 2009 after 120 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- 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 K944711 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053368: Interproximal Reduction System, Dentsply International (2006) Summary page 1.
- K082827: A-Dec/W&H Profin Reciprocating Contra-Angle Handpiece Attachment, A-Dec, Inc. (2009) Summary page 1.

## Indications for use
The dental contra-angle handpiece "KOMET - OS30" is intended for mechanical interproximal enamel reduction (stripping, slenderizing) in use of an oscillating movement

Source page: https://510kreport.com/device/K090548
Methodology: https://510kreport.com/methodology