# K132445: Piezon 250

- Pathway: 510(k) (Special)
- Applicant: E.M.S Electro Medical Systems S.A
- Decided: Dec 6, 2013 after 122 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: 1 generation back to K953026 (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)
- K953026: Minipiezon, Electro Medical Systems SA (1995) Summary page 1.
- K093000: Ems Piezon Master 700, E.M.S Electro Medical Systems S.A (2010) Summary page 1.

## Indications for use
The PIEZON 250 is a device for delivering ultrasonic movement and irrigant to a stainless steel tip which is used by a dentist or dental hygienist. The indications for use are: * Periodontal pocket lavage with simultaneous ultrasonic tip movement * Scaling and root planing * Removal of supra and subgingival calculus and stains from teeth

Source page: https://510kreport.com/device/K132445
Methodology: https://510kreport.com/methodology