# K223340: EDS Calculus Softener TURBO CR

- Pathway: 510(k) (Traditional)
- Applicant: Essential Dental Systems, Inc.
- Decided: Dec 11, 2023 after 405 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 K903163 (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)
- K903163: Periodontal Debriding Solution E, Dentsply Intl. (1990) Summary page 5.

## Indications for use
Softens dental calculus, tartar, and/or plaque to facilitate easier removal; Reduces scaling time; May be used in hand and ultrasonic scaling procedures.

Source page: https://510kreport.com/device/K223340
Methodology: https://510kreport.com/methodology