510(k) · Cleared
ClearedPower Plus 25K Model, S1000, Power Plus 30K Model,S1001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tpc Advanced Technology, Inc. · ELC Scaler, Ultrasonic
Cleared on Jan 29, 1999 as substantially equivalent to K950256 (Parkell, Inc., 1995) and 1 other predicate after a 151-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Jan 29, 1999
- Review
- 151 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K950256 (1995). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK950256 TURBO 25/30Parkell, Inc. · 1995
- This deviceK983029 Power Plus 25K Model, S1000, Power Plus 30K Model,S1001Tpc Advanced Technology, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK994203 Art-M3 25K, Model M3-1-ART2-A1; Art-M3 30K, Model M3-1-ART3-A1Bonart Co., Ltd. · 2000
Most influential descendants
Showing 1 of 1 · See all- K994203Art-M3 25K, Model M3-1-ART2-A1; Art-M3 30K, Model M3-1-ART3-A1Bonart Co., Ltd. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950256 | TURBO 25/30 | Parkell, Inc. | 1995 | — |
| 0 (this device) | K983029 | Power Plus 25K Model, S1000, Power Plus 30K Model,S1001 | Tpc Advanced Technology, Inc. | 1999 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K950256 | TURBO 25/30Summary page 1…sification Name: Ultrasonic Scaler 21 CFR 872.4850 14.3 IDENTIFICATION OF PREDICATE DEVICE Company Device 510(k) No. Date Cleared Parkell Turbo 25/30 Ultrasonic Scaler K950256 04/04/95 Tony Riso Co. 25/30 Multi-Function Ultrasonic K964320 01/23/97 Scaler 141 Power Plus Scaler Original… | 1995 |
| * | K964320 | Tony Riso 25/30 Multifunction ScalerSummary page 1…CATION OF PREDICATE DEVICE Company Device 510(k) No. Date Cleared Parkell Turbo 25/30 Ultrasonic Scaler K950256 04/04/95 Tony Riso Co. 25/30 Multi-Function Ultrasonic K964320 01/23/97 Scaler 141 Power Plus Scaler Original Premarket 510(k) Notification 14.4 14.5 14.6 DEVICE DESCRIPTI… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K994203 | Art-M3 25K, Model M3-1-ART2-A1; Art-M3 30K, Model M3-1-ART3-A1 | 2000 | 0 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K994203 (Bonart Co., Ltd., 2000) has gone furthest, with 0 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?
The Power Plus 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/K983029 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983029: Power Plus 25K Model, S1000, Power Plus 30K Model,S1001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983029
Report an extraction error
Are you the manufacturer?
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