510(k) · Cleared
ClearedDental Ultrasonic Scaler Inserts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hu-Friedy Mfg. Co., Inc. · ELC Scaler, Ultrasonic
Cleared on Oct 7, 1995 after a 47-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Oct 7, 1995
- Review
- 47 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK953919 Dental Ultrasonic Scaler InsertsHu-Friedy Mfg. Co., Inc. · 1995
- Descendant · cites it directly · 2 of its ownK012060 Modification to:HU-Friedy Brand Satin Swivel Ultrasonic InsertHu-Friedy Mfg. Co., Inc. · 2001
- Descendant · 2 generations on · 0 of its ownK210832 EVOCLEAN CLEANsert Ultrasonic InsertTtbio Corp. · 2022
- Descendant · cites it directly · 0 of its ownK092417 Insight Ultrasonic InsertsDiscus Dental, LLC · 2009
Most influential descendants
Showing 3 of 3 · See all- K012060Modification to:HU-Friedy Brand Satin Swivel Ultrasonic InsertHu-Friedy Mfg. Co., Inc. · 2001 · cites it directly2descendants
- K210832EVOCLEAN CLEANsert Ultrasonic InsertTtbio Corp. · 2022 · 2 generations on0descendants
- K092417Insight Ultrasonic InsertsDiscus Dental, LLC · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953919 | Dental Ultrasonic Scaler Inserts | Hu-Friedy Mfg. Co., Inc. | 1995 | — |
| +1 | K012060 | Modification to:HU-Friedy Brand Satin Swivel Ultrasonic Insert | Hu-Friedy Mfg. Co., Inc. | 2001 | — |
| +2 | K210832 | EVOCLEAN CLEANsert Ultrasonic Insert | Ttbio Corp. | 2022 | — |
| +1 | K092417 | Insight Ultrasonic Inserts | Discus Dental, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2009 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
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, K012060 (Hu-Friedy Mfg. Co., Inc., 2001) 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 | — |
https://510kreport.com/device/K953919 · printed Nov 5, 2026
Cite this page
510(k) Report. “K953919: Dental Ultrasonic Scaler Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K953919
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026