# K040396: Ultrasonic Scaler Elegance MS-10 (25K)

- Pathway: 510(k) (Traditional)
- Applicant: Rolence Enteprise, Inc.
- Decided: Apr 22, 2004 after 65 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
THE ELEGANCE MS-10 (25K) ULTRASONIC SCALER IS DESIGNED FOR USE IN PROPHYLAXIS TREATMENTS PERIODONTIA, AND OTHER AREAS OF OPERATIVE DENTISTRY.

Source page: https://510kreport.com/device/K040396
Methodology: https://510kreport.com/methodology