# K050354: Perioscan Ultrasonic Scaler

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Mar 21, 2005 after 35 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: 3 generations back to K896749 (1990). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022328: Ems Piezon Master 600, Electro Medical Systems SA (2002) Summary page 1.

## Most influential descendants
- K072107: Perioscan, Model: D 3496 (2008), 0 descendants of its own

## Indications for use
The Sirona Dental Systems PerioScan Ultrasonic Scaler is an ultrasonic scaler intended for use in the following dental and periodontal applications: * Removal of supragingival and subgingival calculus * Periodontal therapy * Preparing proximal cavities (micropreparation) * Seating tooth-colored inlays and onlays with highly thixotropic dual curing cements * Root canal irrigation * Retrograde root canal treatment

Source page: https://510kreport.com/device/K050354
Methodology: https://510kreport.com/methodology