510(k) · Cleared
ClearedBiosonic Suvi Piezeoelectric Scaler and Polisher
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coltene/Whaledent · ELC Scaler, Ultrasonic
Cleared on Aug 23, 2013 as substantially equivalent to K110173 (E.M.S Electro Medical Systems S.A, 2011) after a 217-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Aug 23, 2013
- Review
- 217 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K900709 (1990). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK900709 Air Flow SiiElectro Medical Systems (Ems Sa) · 1990
- 4 generations backK991857 Airflow HandyElectro Medical Systems, Inc. · 1999
- 3 generations backK022119 Ems Air-Flow Handy 2 Dental HandpieceElectro Medical Systems SA · 2002
- 2 generations backK092289 Ems Air-Flow Handy PerioE.M.S Electro Medical Systems S.A · 2009
- 1 generation backK110173 Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011
- This deviceK130137 Biosonic Suvi Piezeoelectric Scaler and PolisherColtene/Whaledent · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K900709 | Air Flow Sii | Electro Medical Systems (Ems Sa) | 1990 | — |
| −4 | K991857 | Airflow Handy | Electro Medical Systems, Inc. | 1999 | — |
| −3 | K022119 | Ems Air-Flow Handy 2 Dental Handpiece | Electro Medical Systems SA | 2002 | — |
| −2 | K092289 | Ems Air-Flow Handy Perio | E.M.S Electro Medical Systems S.A | 2009 | — |
| −1 | K110173 | Ems Air-Flow Master Piezon | E.M.S Electro Medical Systems S.A | 2011 | — |
| 0 (this device) | K130137 | Biosonic Suvi Piezeoelectric Scaler and Polisher | Coltene/Whaledent | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 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? (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 |
|---|---|---|---|
| * | K110173 | Ems Air-Flow Master PiezonSummary page 4…EMS Air Flow) Ultrasonic Scaler and Polisher Unit. This device was granted marketing clearance by FDA on April 7, 2011 under 510(k) Accession Number KI 110173. Both of these products are electrically powered, electromechanical devices designed for use in dental applica… | 2011 |
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 23 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- None of the 15 ancestors has a recall.
- 5 other devices also cite its predicate K110173.
How does its category compare?
All ELC devicesELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 BioSonic Suvi ultrasonic scaler is intended for use in dental applications such as supra and subgingival scaling, periodontal therapy, endodontic procedures, cavity preparation, and restorative dentistry.
The BioSonic Suvi Air Polisher is intended for use in the cleaning, surface preparation and polishing of teeth by the projection of water, air and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces or smooth surfaces of teeth. The RioSonic Suvi Air Polisher is also indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130137 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130137: Biosonic Suvi Piezeoelectric Scaler and Polisher.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130137
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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