510(k) · Cleared
ClearedPerioscan, Model: D 3496
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirona Dental Systems GmbH · ELC Scaler, Ultrasonic
Cleared on Feb 14, 2008 as substantially equivalent to K050354 (Sirona Dental Systems GmbH, 2005) and 1 other predicate after a 198-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Feb 14, 2008
- Review
- 198 days
- Class
- Class II
- Product code
- ELC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K896749 (1990). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK896749 Piezon Master 400Electro Medical Systems (Ems Sa) · 1990
- 3 generations backK992504 Ems Kermit(Ems Sa) Electro Medical Systems · 2000
- 2 generations backK022328 Ems Piezon Master 600Electro Medical Systems SA · 2002
- 1 generation backK033640 Siroson L and Sirosonic L Ultrasonic ScalersSirona Dental Systems GmbH · 2003
- This deviceK072107 Perioscan, Model: D 3496Sirona Dental Systems GmbH · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K896749 | Piezon Master 400 | Electro Medical Systems (Ems Sa) | 1990 | — |
| −3 | K992504 | Ems Kermit | (Ems Sa) Electro Medical Systems | 2000 | — |
| −2 | K022328 | Ems Piezon Master 600 | Electro Medical Systems SA | 2002 | — |
| −1 | K033640 | Siroson L and Sirosonic L Ultrasonic Scalers | Sirona Dental Systems GmbH | 2003 | — |
| 0 (this device) | K072107 | Perioscan, Model: D 3496 | Sirona Dental Systems GmbH | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2005 | 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? (2)
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 |
|---|---|---|---|
| * | K050354 | Perioscan Ultrasonic ScalerSummary page 1…Common/Usual Name: Ultrasonic Scaler Classification Name: Ultrasonic Scaler 3. PREDICATE DEVICE Sirona PerioScan Ultrasonic Scaler (K050354) and SiroSonic L Ultrasonic Scaler (K033640). 4. INTENDED USE The Sirona Dental Systems PerioScan is an ultra… | 2005 |
| * | K033640 | Siroson L and Sirosonic L Ultrasonic ScalersSummary page 1…Classification Name: Ultrasonic Scaler 3. PREDICATE DEVICE Sirona PerioScan Ultrasonic Scaler (K050354) and SiroSonic L Ultrasonic Scaler (K033640). 4. INTENDED USE The Sirona Dental Systems PerioScan is an ultrasonic scaler that aids in the recognition of… | 2003 |
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 18 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- None of the 7 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. 2008, 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 Sirona Dental Systems PerioScan Ultrasonic Scaler is an ultrasonic scaler that aids in the recognition of calculus and intended for use in the following dental and periodontal applications:
* Aiding in subgingival calculus detection
* Calculus removal (subgingival and supragingival)
* Retrograde root treatment
* Endodontics
* Insertion of inlays
* Micropreparation (cavity preparation)
* Periodontology
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072107 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072107: Perioscan, Model: D 3496.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072107
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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