510(k) · Cleared
ClearedInsight Ultrasonic Inserts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Discus Dental, LLC · ELC Scaler, Ultrasonic
Cleared on Dec 11, 2009 as substantially equivalent to K051776 (Discus Dental, Inc., 2005) and 2 other predicates after a 126-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Dec 11, 2009
- Review
- 126 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K953919 (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 | 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 | — |
| 0 (this device) | K092417 | Insight Ultrasonic Inserts | Discus Dental, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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? (3)
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 |
|---|---|---|---|
| * | K051776 | Protege Ultrasonic InsertSummary page 2…serts: Predicate Device Company 5 10(k) No. Prot6g6 Ultrasonic Inserts Discus Dental K05 1776 Ultrasonic Scaler Inserts Hu-Friedy MEG. CO., Inc. K953919 Satin Swivel Ultrasonic Inserts… | 2005 |
| * | K953919 | Dental Ultrasonic Scaler InsertsSummary page 2…10(k) No. Prot6g6 Ultrasonic Inserts Discus Dental K05 1776 Ultrasonic Scaler Inserts Hu-Friedy MEG. CO., Inc. K953919 Satin Swivel Ultrasonic Inserts Hu-Friedy MFG. CO., Inc. K0 12060 END OF SUMM4ARY OF SAFETY A… | 1995 |
| * | K012060 | Modification to:HU-Friedy Brand Satin Swivel Ultrasonic InsertSummary page 2…K05 1776 Ultrasonic Scaler Inserts Hu-Friedy MEG. CO., Inc. K953919 Satin Swivel Ultrasonic Inserts Hu-Friedy MFG. CO., Inc. K0 12060 END OF SUMM4ARY OF SAFETY AND EFFECTIVENESS Discus Dental, LLC. B-2… | 2001 |
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 14 years and passes through 2 companies; a new generation was cleared every 8.4 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. 2009, 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 Insight Ultrasonic Insert is designed to be used in the handpiece of any conventional magnetostrictive ultrasonic scaler, an instrument used for dental cleaning and removal of tenacious calculus and plaque using ultrasonic vibration. The last 4.3 mm of the insert tip vibrates ultrasonically to remove the tenacious calculus from the teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092417 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092417: Insight Ultrasonic Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092417
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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