510(k) · Cleared
ClearedY-MIC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micron Corporation · ELC Scaler, Ultrasonic
Cleared on Dec 22, 2016 as substantially equivalent to K080089 (Sybron Dental Specialties, Inc., 2008) after a 191-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Dec 22, 2016
- Review
- 191 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K944714 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK944714 W&H Corsair ScalerA-Dec, Inc. · 1995
- 2 generations backK033812 Siroair L Air ScalerSirona Dental Systems GmbH · 2004
- 1 generation backK080089 Sonicflex 2003 and Sonicflex Lux 2003 L with Instrument TipsSybron Dental Specialties, Inc. · 2008
- This deviceK161639 Y-MICMicron Corporation · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944714 | W&H Corsair Scaler | A-Dec, Inc. | 1995 | — |
| −2 | K033812 | Siroair L Air Scaler | Sirona Dental Systems GmbH | 2004 | — |
| −1 | K080089 | Sonicflex 2003 and Sonicflex Lux 2003 L with Instrument Tips | Sybron Dental Specialties, Inc. | 2008 | — |
| 0 (this device) | K161639 | Y-MIC | Micron Corporation | 2016 | — |
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 |
|---|---|---|---|
| * | K080089 | Sonicflex 2003 and Sonicflex Lux 2003 L with Instrument TipsSummary page 4…ication Name: Ultrasonic scaler (21 CFR 872.4850) Regulatory Class: II Product Code: ELC 807.92(a) (3) PREDICATE DEVICE Sybron Dental Specialties, Inc. SONICflex 2003, K080089 No reference devices were used in this submission. 807.92(a) (4) DESCRIPTION OF DEVICE The prosed device is used by dental prof… | 2008 |
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 21 years and passes through 4 companies; a new generation was cleared every 8.3 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. 2016, 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 proposed device is intended to remove plaque and calculus in the areas of dental scaling, and for use in periodontics, endodontics and prosthetic by dental professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161639: Y-MIC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161639
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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