# K060171: Cleanse S+ Ultrasonic Scaler

- Pathway: 510(k) (Traditional)
- Applicant: Dmetec.Co., Ltd.
- Decided: Mar 29, 2006 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
Longest line of descent: 3 generations back to K896749 (1990). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033044: Dream Cleanse S Scaler, Dream Compact S Scaler, American Green Dent. Mfg, Inc. (2004). Our reading of the summary gave K033041, FDA’s number for Acon Quik-Check II Home Pregnancy Test Strip (ACON Laboratories, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “America Green Dent Cleanse S”.
- K050710: Minimaster Ultrasonic Scaler, E.M.S Electro Medical Systems S.A (2005) Summary page 2.
- K022328: Ems Piezon Master 600, Electro Medical Systems SA (2002) Summary page 2.
- K953026: Minipiezon, Electro Medical Systems SA (1995) Summary page 1.

## Most influential descendants
- K170104: Compact S, Compact S (Led) (2017), 0 descendants of its own

## Indications for use
Intended for use during dental procedures to: -Remove 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, cleaning, and irrigating root canals - Preparing approximal cavities - Cementing inlays and onlays - Retrograde preparation of root canals

Source page: https://510kreport.com/device/K060171
Methodology: https://510kreport.com/methodology