# K210832: EVOCLEAN CLEANsert Ultrasonic Insert

- Pathway: 510(k) (Traditional)
- Applicant: Ttbio Corp.
- Decided: Feb 2, 2022 after 320 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: 2 generations back to K953919 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012060: Modification to:HU-Friedy Brand Satin Swivel Ultrasonic Insert, Hu-Friedy Mfg. Co., Inc. (2001) Summary page 4.

## Indications for use
To be used by dental professionals for dental cleaning and periodontal(gum) therapy to remove calculus from the teeth.

Source page: https://510kreport.com/device/K210832
Methodology: https://510kreport.com/methodology