# K060275: Piezotome

- Pathway: 510(k) (Traditional)
- Applicant: Satelec
- Decided: May 3, 2006 after 90 days
- Product code: ELC (Scaler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 872.4850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K942139 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050895: Surpasson P5 Newtron, Satelec (2005) Summary page 1.

## Indications for use
Periodontics Endodontics Scaling Prosthesis Please refer to the attached listing for a detailed description. Periodontics: * Root planing * Initial therapy * Treatment of periodontal pockets * Treatment of furcations * Maintenance therapy * Implant maintenance Endodontics: * Canal preparation * Canal cleaning * Canal filling * Gutta percha condensation * Treatment resumption * Retro Surgery * Micro Retro Surgery Scaling (prophylaxis): * Interdental junction treatment * Tooth neck and subgingival treatment * Treatment of large deposits * Treatment of coating and tobacco stains * Interproximal treatment Prosthesis (conservative/restorative): * Inlay/onlay condensation * Amalgam plugging * Loosening prostheses (bridge, crown, post, pivot...)

Source page: https://510kreport.com/device/K060275
Methodology: https://510kreport.com/methodology