# K053578: Scorpion Ultrasonic Scaling Inserts

- Pathway: 510(k) (Traditional)
- Applicant: Scorpion
- Decided: Jul 14, 2006 after 204 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 K942139 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033764: SP Newtron Module, Satelec (2004) Summary page 1.
- K992504: Ems Kermit, (Ems Sa) Electro Medical Systems (2000) Summary page 1.
- K960889: Sapphire Plus Scaler Mod. 300114/Plugger Mod. 300115/Cutting Mod. 300116/Spreader Mod. 300117 Tips, San Diego Swiss Machining, Inc. (1996) Summary page 1.

## Indications for use
Scorpion ultrasonic scaling inserts are used by dental professionals during dental cleaning procedures to remove supragingival calculus deposits from the teeth.

Source page: https://510kreport.com/device/K053578
Methodology: https://510kreport.com/methodology