510(k) · Cleared
ClearedSapphire Plus Scaler Mod. 300114/Plugger Mod. 300115/Cutting Mod. 300116/Spreader Mod. 300117 Tips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
San Diego Swiss Machining, Inc. · ELC Scaler, Ultrasonic
Cleared on May 10, 1996 after a 67-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- May 10, 1996
- Review
- 67 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 5 citing it directly.
- This deviceK960889 Sapphire Plus Scaler Mod. 300114/Plugger Mod. 300115/Cutting Mod.…San Diego Swiss Machining, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK132609 Eds Ultrasonic TipsEssential Dental Systems, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK230641 Ultrasonic Scaler TipsGuilin Refine Medical Instrument Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK182145 tün® ultrasonic tips product familyEngineered Endodontics · 2019
- Descendant · cites it directly · 0 of its ownK122501 Aei DR. Terauchi Ultrasonic TipsAmerican Eagle Instruments, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK053578 Scorpion Ultrasonic Scaling InsertsScorpion · 2006
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K132609Eds Ultrasonic TipsEssential Dental Systems, Inc. · 2014 · cites it directly1descendant
- K230641Ultrasonic Scaler TipsGuilin Refine Medical Instrument Co., Ltd. · 2023 · cites it directly0descendants
- K182145tün® ultrasonic tips product familyEngineered Endodontics · 2019 · 2 generations on0descendants
- K122501Aei DR. Terauchi Ultrasonic TipsAmerican Eagle Instruments, Inc. · 2013 · cites it directly0descendants
- K053578Scorpion Ultrasonic Scaling InsertsScorpion · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960889 | Sapphire Plus Scaler Mod. 300114/Plugger Mod. 300115/Cutting Mod.… | San Diego Swiss Machining, Inc. | 1996 | — |
| +1 | K132609 | Eds Ultrasonic Tips | Essential Dental Systems, Inc. | 2014 | — |
| +1 | K230641 | Ultrasonic Scaler Tips | Guilin Refine Medical Instrument Co., Ltd. | 2023 | — |
| +2 | K182145 | tün® ultrasonic tips product family | Engineered Endodontics | 2019 | — |
| +1 | K122501 | Aei DR. Terauchi Ultrasonic Tips | American Eagle Instruments, Inc. | 2013 | — |
| +1 | K053578 | Scorpion Ultrasonic Scaling Inserts | Scorpion | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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? (5)
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 |
|---|---|---|---|
| * | — | Piezon Master 400 Scalers Tips Named without a submission number | |
| * | — | Cavitron Ultrasonic Tips Models J-3 and S-3 Named without a submission number | |
| * | — | Piezo-Electric D Files Named without a submission number | |
| * | — | Ultrasonic Neosonics-D Named without a submission number | |
| * | — | Endosonic files Named without a submission number |
What descends from it? (6)
5 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, K132609 (Essential Dental Systems, Inc., 2014) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The San Diego Swiss Machining Sapphire Plus® Tips are utilized in reconstructive dental procedures (crown preparation), periodontic preparative procedures, tissue scaling, plaque/bone removal, endodontic retreatment and root preparation.
The devices are used during dertal cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of ultrasonic vibration and in various endodcntic applications to prepare the tooth and/or root of the tooth for repair.
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/K960889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960889: Sapphire Plus Scaler Mod. 300114/Plugger Mod. 300115/Cutting Mod. 300116/Spreader Mod. 300117 Tips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960889
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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