# K033812: Siroair L Air Scaler

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Feb 23, 2004 after 76 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: 1 generation back to K944714 (1995). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944714: W&H Corsair Scaler, A-Dec, Inc. (1995) Summary page 1.

## Most influential descendants
- K080089: Sonicflex 2003 and Sonicflex Lux 2003 L with Instrument Tips (2008), 1 descendant of its own
- K161639: Y-MIC (2016), 0 descendants of its own
- K043497: Air Solfy, Models as-4H, as-4H-O, as-4H-V, as-4H-OV, as-1,as-1-0,as-1-V, as-1-OV (2005), 0 descendants of its own

## Indications for use
The SIROAIR L Air Scaler is an air-powered scaler intended for use in calculus removal (subgingival and supragingival).

Source page: https://510kreport.com/device/K033812
Methodology: https://510kreport.com/methodology