510(k) · Cleared
ClearedUltrasonic Scaler, Models Uds-N1, Uds-N2. Uds-J, Uds-K, Uds-L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guilin Woodpecker Medical Instrument Co., Ltd. · ELC Scaler, Ultrasonic
Cleared on Aug 21, 2006 after a 244-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Aug 21, 2006
- Review
- 244 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK053555 Ultrasonic Scaler, Models Uds-N1, Uds-N2. Uds-J, Uds-K, Uds-LGuilin Woodpecker Medical Instrument Co., Ltd. · 2006
- Descendant · cites it directly · 2 of its ownK140233 Ultrasonic ScalerNanning Baolai Medical Instrument Co., Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK163414 Ultrasonic scalerNanning VV Dental Co., Ltd. · 2017
- Descendant · 3 generations on · 0 of its ownK240707 Ultrasonic Scaler…Shenzhen Micro Electric Intelligence Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK222096 Endo Ultrasonic ActivatorFoshan Coxo Medical Instrument Co., Ltd. · 2023
Most influential descendants
Showing 4 of 4 · See all- K140233Ultrasonic ScalerNanning Baolai Medical Instrument Co., Ltd. · 2015 · cites it directly2descendants
- K163414Ultrasonic scalerNanning VV Dental Co., Ltd. · 2017 · 2 generations on1descendant
- K240707Ultrasonic Scaler…Shenzhen Micro Electric Intelligence Co., Ltd. · 2024 · 3 generations on0descendants
- K222096Endo Ultrasonic ActivatorFoshan Coxo Medical Instrument Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053555 | Ultrasonic Scaler, Models Uds-N1, Uds-N2. Uds-J, Uds-K, Uds-L | Guilin Woodpecker Medical Instrument Co., Ltd. | 2006 | — |
| +1 | K140233 | Ultrasonic Scaler | Nanning Baolai Medical Instrument Co., Ltd. | 2015 | — |
| +2 | K163414 | Ultrasonic scaler | Nanning VV Dental Co., Ltd. | 2017 | — |
| +3 | K240707 | Ultrasonic Scaler… | Shenzhen Micro Electric Intelligence Co., Ltd. | 2024 | — |
| +1 | K222096 | Endo Ultrasonic Activator | Foshan Coxo Medical Instrument Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ELC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ELC device
- #1 K260773 Varios Combi Pro2score 12.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K140233 (Nanning Baolai Medical Instrument Co., Ltd., 2015) has gone furthest, with 2 descendants of its own.
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ELC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ELC
104in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELC
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELC
284in 2025
MAUDE reports naming product code ELC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 92 | 0 | 12 |
| 2008 | 4 | 216 | 0 | 58 |
| 2009 | 4 | 121 | 0 | 108 |
| 2010 | 4 | 201 | 0 | 79 |
| 2011 | 3 | 122 | 0 | 5 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 13 | 174 | 0 | 6 |
| 2014 | 6 | 193 | 0 | 37 |
| 2015 | 5 | 150 | 0 | 135 |
| 2016 | 3 | 88 | 0 | 169 |
| 2017 | 2 | — | 0 | 356 |
| 2018 | 1 | — | 0 | 289 |
| 2019 | 4 | 192 | 0 | 302 |
| 2020 | 1 | — | 0 | 164 |
| 2021 | 3 | 196 | 0 | 166 |
| 2022 | 2 | — | 2 | 165 |
| 2023 | 5 | 258 | 0 | 210 |
| 2024 | 4 | 104 | 0 | 219 |
| 2025 | 2 | — | 0 | 284 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053555 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053555: Ultrasonic Scaler, Models Uds-N1, Uds-N2. Uds-J, Uds-K, Uds-L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053555
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026