# K033044: Dream Cleanse S Scaler, Dream Compact S Scaler

- Pathway: 510(k) (Traditional)
- Applicant: American Green Dent. Mfg, Inc.
- Decided: Dec 21, 2004 after 449 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K060171: Cleanse S+ Ultrasonic Scaler (2006), 1 descendant of its own
- K170104: Compact S, Compact S (Led) (2017), 0 descendants of its own

## Indications for use
The Dream Cleans "S" Scaler and Dream Compact "S" scalers are hand held ultrasonic instruments used for removal of supragingival and subgingival calculus and stains from teeth. They are also used for periodontal scaling and root planing.

Source page: https://510kreport.com/device/K033044
Methodology: https://510kreport.com/methodology