# K991874: Ems Surface Mount Scaler

- Pathway: 510(k) (Traditional)
- Applicant: (Ems Sa) Electro Medical Systems
- Decided: Jul 30, 1999 after 58 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). 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)
- K953026: Minipiezon, Electro Medical Systems SA (1995) Summary page 1.

## Indications for use
The EMS Surface Mount Scaler is indicated for use in: Removal of supra and subgingival calculus deposits and stains from the teeth Periodontal poclzet 1avage with simultaneous ultrasonic tip movement Scaling and root planing

Source page: https://510kreport.com/device/K991874
Methodology: https://510kreport.com/methodology