510(k) · Cleared
ClearedArt-M3 25K, Model M3-1-ART2-A1; Art-M3 30K, Model M3-1-ART3-A1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bonart Co., Ltd. · ELC Scaler, Ultrasonic
Cleared on Mar 6, 2000 as substantially equivalent to K983029 (Tpc Advanced Technology, Inc., 1999) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Mar 6, 2000
- Review
- 84 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K950256 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950256 | TURBO 25/30 | Parkell, Inc. | 1995 | — |
| −1 | K983029 | Power Plus 25K Model, S1000, Power Plus 30K Model,S1001 | Tpc Advanced Technology, Inc. | 1999 | — |
| 0 (this device) | K994203 | Art-M3 25K, Model M3-1-ART2-A1; Art-M3 30K, Model M3-1-ART3-A1 | Bonart Co., Ltd. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (2)
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 |
|---|---|---|---|
| * | K983029 | Power Plus 25K Model, S1000, Power Plus 30K Model,S1001Summary page 1…Classification Name; Ultrasonic Scaler 21 CFR 872.4850 14.3 IDENTIFICATION OF PREDICATE DEVICE Company Device 510(k) No. Date Cleared TPC Advanced Power Plus Scaler K983029 01/29/99 Technology ,Inc. Tony Riso Co. 25/30 Multi-Function K964320 01/23/97 Ultrasonic Scaler CONFIDENTIAL PAGE: 1bd === P… | 1999 |
| * | K964320 | Tony Riso 25/30 Multifunction ScalerSummary page 1…ICATION OF PREDICATE DEVICE Company Device 510(k) No. Date Cleared TPC Advanced Power Plus Scaler K983029 01/29/99 Technology ,Inc. Tony Riso Co. 25/30 Multi-Function K964320 01/23/97 Ultrasonic Scaler CONFIDENTIAL PAGE: 1bd ART Scaler Original Premarket 510(k) Notification 144 DEVIC… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 3 ancestors has a recall.
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?
The BONART CO., LTD. ART Ultrasonic Scaler is intended for use during dental cleaning and periodontal therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994203: Art-M3 25K, Model M3-1-ART2-A1; Art-M3 30K, Model M3-1-ART3-A1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994203
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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