# K982793: Piezo Tronic

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Devices, Inc.
- Decided: Oct 28, 1998 after 79 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 K896749 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896749: Piezon Master 400, Electro Medical Systems (Ems Sa) (1990) Summary page 3.
- (no number) Dentsply Bobcat®: named in the summary without a submission number
- (no number) Cavitron® Model 3000: named in the summary without a submission number

## Indications for use
The Piezo Tronic is an ultrasonic scaler intended for use during dental cleaning and periodontal (gum) therapy to remove plaque and calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Source page: https://510kreport.com/device/K982793
Methodology: https://510kreport.com/methodology