510(k) · Cleared
ClearedUltrasonic Scaler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanning Baolai Medical Instrument Co., Ltd. · ELC Scaler, Ultrasonic
Cleared on Apr 6, 2015 as substantially equivalent to K053555 (Guilin Woodpecker Medical Instrument Co., Ltd., 2006) after a 431-day review. Its family tree reaches back 1 generation to 2006. 2 later devices descend from it.
- Decided
- Apr 6, 2015
- Review
- 431 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053555 (2006). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK053555 Ultrasonic Scaler, Models Uds-N1, Uds-N2. Uds-J, Uds-K, Uds-LGuilin Woodpecker Medical Instrument Co., Ltd. · 2006
- This deviceK140233 Ultrasonic ScalerNanning Baolai Medical Instrument Co., Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK163414 Ultrasonic scalerNanning VV Dental Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK240707 Ultrasonic Scaler…Shenzhen Micro Electric Intelligence Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053555 | Ultrasonic Scaler, Models Uds-N1, Uds-N2. Uds-J, Uds-K, Uds-L | Guilin Woodpecker Medical Instrument Co., Ltd. | 2006 | — |
| 0 (this device) | K140233 | Ultrasonic Scaler | Nanning Baolai Medical Instrument Co., Ltd. | 2015 | — |
| +1 | K163414 | Ultrasonic scaler | Nanning VV Dental Co., Ltd. | 2017 | — |
| +2 | K240707 | Ultrasonic Scaler… | Shenzhen Micro Electric Intelligence Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K053555 | Ultrasonic Scaler, Models Uds-N1, Uds-N2. Uds-J, Uds-K, Uds-LSummary page 4…CFR 872.4850 Date prepared April 1th, 2015 Number of submission K140233 Predicate Device(s): Guilin Woodpecker USD-L ultrasonic scaler, K053555 Device Description: Ultrasonic scaler employs piezoelectric technology to produce a stead… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163414 | Ultrasonic scaler | 2017 | 1 |
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?
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140233: Ultrasonic Scaler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140233
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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