# K053555: Ultrasonic Scaler, Models Uds-N1, Uds-N2. Uds-J, Uds-K, Uds-L

- Pathway: 510(k) (Traditional)
- Applicant: Guilin Woodpecker Medical Instrument Co., Ltd.
- Decided: Aug 21, 2006 after 244 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K140233: Ultrasonic Scaler (2015), 2 descendants of its own
- 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
- K222096: Endo Ultrasonic Activator (2023), 0 descendants of its own

## Indications for use
Model :UDS-J/K/NIfN2 1. Removing supra and sub gingival calculus deposits and stains from the teeth 2. Periodontal pocket lavage with simultaneous ultrasonic tip movement Model: UDS-L : 1. Removing supra and sub gingival calculus deposits and stains from the teeth 2. Periodontal pocket lavage with simultaneous ultrasonic tip movement 3. Preparing, cleaning, and irrigating root canals 4. Retrograde preparation of root canals

Source page: https://510kreport.com/device/K053555
Methodology: https://510kreport.com/methodology