# 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

- Pathway: 510(k) (Traditional)
- Applicant: J. Morita USA, Inc.
- Decided: Mar 21, 2005 after 94 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 K944714 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033812: Siroair L Air Scaler, Sirona Dental Systems GmbH (2004) Summary page 2.

## Indications for use
The Air Solfy is a dental air-powered handpiece scaler and tips that can remove calculus deposits from the teeth by application of an air-powered vibrating scaler tip to the teeth during dental cleaning and periodontal therapy.

Source page: https://510kreport.com/device/K043497
Methodology: https://510kreport.com/methodology