# K140233: Ultrasonic Scaler

- Pathway: 510(k) (Traditional)
- Applicant: Nanning Baolai Medical Instrument Co., Ltd.
- Decided: Apr 6, 2015 after 431 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 K053555 (2006). 1 ancestor in all.
2 later devices descend from it; 1 cites 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)
- K053555: Ultrasonic Scaler, Models Uds-N1, Uds-N2. Uds-J, Uds-K, Uds-L, Guilin Woodpecker Medical Instrument Co., Ltd. (2006) Summary page 4.

## Most influential descendants
- K163414: Ultrasonic scaler (2017), 1 descendant of its own
- K240707: Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017) (2024), 0 descendants of its own

## Indications for use
The ultrasonic scaler is intended to: 1. Remove supra and sub gingival calculus deposits and stain from the teeth; 2. Carry out periodontal pocket lavage with simultaneous ultrasonic tip movement; 3. Clean and irrigate root canals.

Source page: https://510kreport.com/device/K140233
Methodology: https://510kreport.com/methodology