# K092417: Insight Ultrasonic Inserts

- Pathway: 510(k) (Traditional)
- Applicant: Discus Dental, LLC
- Decided: Dec 11, 2009 after 126 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051776: Protege Ultrasonic Insert, Discus Dental, Inc. (2005) Summary page 2.
- K953919: Dental Ultrasonic Scaler Inserts, Hu-Friedy Mfg. Co., Inc. (1995) Summary page 2.
- K012060: Modification to:HU-Friedy Brand Satin Swivel Ultrasonic Insert, Hu-Friedy Mfg. Co., Inc. (2001) Summary page 2.

## Indications for use
The Insight Ultrasonic Insert is designed to be used in the handpiece of any conventional magnetostrictive ultrasonic scaler, an instrument used for dental cleaning and removal of tenacious calculus and plaque using ultrasonic vibration. The last 4.3 mm of the insert tip vibrates ultrasonically to remove the tenacious calculus from the teeth.

Source page: https://510kreport.com/device/K092417
Methodology: https://510kreport.com/methodology