510(k) · Cleared
ClearedModification to:HU-Friedy Brand Satin Swivel Ultrasonic Insert
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 Jul 27, 2001 as substantially equivalent to K953919 (Hu-Friedy Mfg. Co., Inc., 1995) after a 25-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Jul 27, 2001
- Review
- 25 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953919 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK953919 Dental Ultrasonic Scaler InsertsHu-Friedy Mfg. Co., Inc. · 1995
- This deviceK012060 Modification to:HU-Friedy Brand Satin Swivel Ultrasonic InsertHu-Friedy Mfg. Co., Inc. · 2001
- Descendant · cites it directly · 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953919 | Dental Ultrasonic Scaler Inserts | Hu-Friedy Mfg. Co., Inc. | 1995 | — |
| 0 (this device) | K012060 | Modification to:HU-Friedy Brand Satin Swivel Ultrasonic Insert | Hu-Friedy Mfg. Co., Inc. | 2001 | — |
| +1 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K953919 | Dental Ultrasonic Scaler InsertsSummary page 1…ic Insert Common name Ultrasonic Insert Classification name Ultrasonic Scaler Legally marketed Device to which equivalence is claimed Hu-Friedy Ultrasonic Scaler Insert K953919 Description of the device The Hu-Friedy® brand Satin Swivel™ ultrasonic insert is similar to the predicate device with the addi… | 1995 |
What descends from it? (2)
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?
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?
To be used by Dental Professionals for dental cleaning and periodontal (gum)
therapy to remove calculus from 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/K012060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012060: Modification to:HU-Friedy Brand Satin Swivel Ultrasonic Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012060
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026