510(k) · Cleared
ClearedSSS, Model 1072001 (Standard 4-Hole Model) & 1072002 (Standard 2-Hole Model)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micron Corp. · ELC Scaler, Ultrasonic
Cleared on Nov 20, 2003 as substantially equivalent to K991239 (Micron Corp., 1999) after a 56-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Nov 20, 2003
- Review
- 56 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991239 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK991239 Vip 60 (2H), Model 115-000-1, Vip 60 (4H), Model 115-000-2Micron Corp. · 1999
- This deviceK032995 SSS, Model 1072001 (Standard 4-Hole Model) & 1072002 (Standard…Micron Corp. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991239 | Vip 60 (2H), Model 115-000-1, Vip 60 (4H), Model 115-000-2 | Micron Corp. | 1999 | — |
| 0 (this device) | K032995 | SSS, Model 1072001 (Standard 4-Hole Model) & 1072002 (Standard 2-Hole Model) | Micron Corp. | 2003 | — |
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 |
|---|---|---|---|
| * | K991239 | Vip 60 (2H), Model 115-000-1, Vip 60 (4H), Model 115-000-2Summary page 1…eeallv Marketed Predicate Device Device Manufacturer 510 (k) Number Air scaler VIP 60 Micron Corporation K991239 6.4 Device Description As with its predicate device, SSS is a n air scaler for use by dental professionals. The basic design of… | 1999 |
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?
- Its one ancestor has no recall.
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?
This air scaler is intended to remove dental plaque, calculus and stain from tooth surface or root by dental professionals only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032995: SSS, Model 1072001 (Standard 4-Hole Model) & 1072002 (Standard 2-Hole Model).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032995
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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