# K170104: Compact S, Compact S (Led)

- Pathway: 510(k) (Traditional)
- Applicant: Dmetec.Co., Ltd.
- Decided: Dec 27, 2017 after 349 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: 4 generations back to K896749 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060171: Cleanse S+ Ultrasonic Scaler, Dmetec.Co., Ltd. (2006) Summary page 4.

## Indications for use
- removing supra and subgingival calculus and stains - periodontal pocket lavage with simultaneous ultrasonic tip movement - scaling and root planning - releasing crowns, bridges, inlays and posts as well as condensing gutta percha - plugging for amalgam condensation - amalgam burnishing - preparing, cleanig, and irrigating root canals - preparing approximal cavites - cementing inlays and onlays - retrograde preparation of root canals

Source page: https://510kreport.com/device/K170104
Methodology: https://510kreport.com/methodology