# K012060: Modification to:HU-Friedy Brand Satin Swivel Ultrasonic Insert

- Pathway: 510(k) (Special)
- Applicant: Hu-Friedy Mfg. Co., Inc.
- Decided: Jul 27, 2001 after 25 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: 1 generation back to K953919 (1995). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953919: Dental Ultrasonic Scaler Inserts, Hu-Friedy Mfg. Co., Inc. (1995) Summary page 1.

## Most influential descendants
- K210832: EVOCLEAN CLEANsert Ultrasonic Insert (2022), 0 descendants of its own
- K092417: Insight Ultrasonic Inserts (2009), 0 descendants of its own

## 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/K012060
Methodology: https://510kreport.com/methodology