# K130137: Biosonic Suvi Piezeoelectric Scaler and Polisher

- Pathway: 510(k) (Traditional)
- Applicant: Coltene/Whaledent
- Decided: Aug 23, 2013 after 217 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: 5 generations back to K900709 (1990). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110173: Ems Air-Flow Master Piezon, E.M.S Electro Medical Systems S.A (2011) Summary page 4.

## Indications for use
The BioSonic Suvi ultrasonic scaler is intended for use in dental applications such as supra and subgingival scaling, periodontal therapy, endodontic procedures, cavity preparation, and restorative dentistry. The BioSonic Suvi Air Polisher is intended for use in the cleaning, surface preparation and polishing of teeth by the projection of water, air and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces or smooth surfaces of teeth. The RioSonic Suvi Air Polisher is also indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

Source page: https://510kreport.com/device/K130137
Methodology: https://510kreport.com/methodology