# K191079: Piezon Built-in Kit, Piezon Built-in Kit LED

- Pathway: 510(k) (Traditional)
- Applicant: E.M.S Electro Medical Systems S.A
- Decided: Aug 16, 2019 after 115 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: 2 generations back to K953026 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132443: Piezon 150, E.M.S Electro Medical Systems S.A (2013) Summary page 4.

## Indications for use
Scaling: - Removal of supragingival and subgingival calculus - Removal of stains

Source page: https://510kreport.com/device/K191079
Methodology: https://510kreport.com/methodology