510(k) · Cleared
ClearedCleanse S+ Ultrasonic Scaler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dmetec.Co., Ltd. · ELC Scaler, Ultrasonic
Cleared on Mar 29, 2006 as substantially equivalent to K033044 (American Green Dent. Mfg, Inc., 2004) and 3 other predicates after a 65-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it.
- Decided
- Mar 29, 2006
- Review
- 65 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K896749 (1990). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK896749 Piezon Master 400Electro Medical Systems (Ems Sa) · 1990
- 2 generations backK992504 Ems Kermit(Ems Sa) Electro Medical Systems · 2000
- 1 generation backK022328 Ems Piezon Master 600Electro Medical Systems SA · 2002
- This deviceK060171 Cleanse S+ Ultrasonic ScalerDmetec.Co., Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK170104 Compact S, Compact S (Led)Dmetec.Co., Ltd. · 2017
Most influential descendants
Showing 1 of 1 · See all- K170104Compact S, Compact S (Led)Dmetec.Co., Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K896749 | Piezon Master 400 | Electro Medical Systems (Ems Sa) | 1990 | — |
| −2 | K992504 | Ems Kermit | (Ems Sa) Electro Medical Systems | 2000 | — |
| −1 | K022328 | Ems Piezon Master 600 | Electro Medical Systems SA | 2002 | — |
| 0 (this device) | K060171 | Cleanse S+ Ultrasonic Scaler | Dmetec.Co., Ltd. | 2006 | — |
| +1 | K170104 | Compact S, Compact S (Led) | Dmetec.Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (4)
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 |
|---|---|---|---|
| * | K033044 | Dream Cleanse S Scaler, Dream Compact S Scaler Our reading of the summary gave K033041, FDA’s number for Acon Quik-Check II Home Pregnancy Test Strip (ACON Laboratories, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “America Green Dent Cleanse S”. | 2004 |
| * | K050710 | Minimaster Ultrasonic ScalerSummary page 2…e S+ is a different unit desit n with different control functions (analog vs.digital), indicator lamps, and footswitchl lock EMS MiniMaster, (K050710), and E,:; Piezon Master 600 (K022328): Saine indications for use. EMS… | 2005 |
| * | K022328 | Ems Piezon Master 600Summary page 2…different control functions (analog vs.digital), indicator lamps, and footswitchl lock EMS MiniMaster, (K050710), and E,:; Piezon Master 600 (K022328): Saine indications for use. EMS miniPiezon legally marketed… | 2002 |
| * | K953026 | MinipiezonSummary page 1…ation: Class 11, 21 CFR 872.485CI 4. Predicate Device Information: America Green Dent Cleanse S K03304,1 EMS Mini Master K953026 EMS Piezon Master 600 K022321 EMS miniPiezon K953026 5. Device Descript… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170104 | Compact S, Compact S (Led) | 2017 | 0 |
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 16 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K170104 (Dmetec.Co., Ltd., 2017) has gone furthest, with 0 descendants 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?
Intended for use during dental procedures to:
-Remove supra and subgingival calculus and stains
- Periodontal pocket lavage with simultaneous ultrasonic tip movement
- Scaling and root planning
- Releasing crowns, bridges, inlays and posts as well as condensing gutta percha
- Plugging for amalgam condensation
- Amalgam burnishing
- Preparing, cleaning, and irrigating root canals
- Preparing approximal cavities
- Cementing inlays and onlays
- Retrograde preparation of root canals
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060171 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060171: Cleanse S+ Ultrasonic Scaler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060171
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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