510(k) · Cleared
ClearedSURGmatic S15 L Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kavo Dental GmbH · EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Cleared on Dec 21, 2021 as substantially equivalent to K140308 (Kaltenbach & Voigt GmbH, 2014) after an 85-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Dec 21, 2021
- Review
- 85 days
- Class
- Class I
- Product code
- EGS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002469 (2001). 6 ancestors in all, the oldest K970953 (1997). No later device cites it as a predicate yet.
- Root · 4 generations backK002469 Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V)W&H Dentalwerk Buermoos GmbH · 2001
- 3 generations backK052741 Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version)…W&H Dentalwerk Buermoos GmbH · 2006
- 2 generations backK092214 Chiropro L SystemBien-Air Dental, SA · 2009 · Recalled
- 1 generation backK140308 Mastersurg / ExpertsurgKaltenbach & Voigt GmbH · 2014
- This deviceK213139 SURGmatic S15 L ProKavo Dental GmbH · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002469 | Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V) | W&H Dentalwerk Buermoos GmbH | 2001 | — |
| −3 | K052741 | Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl.… | W&H Dentalwerk Buermoos GmbH | 2006 | — |
| −2 | K092214 | Chiropro L System | Bien-Air Dental, SA | 2009 | 1 |
| −1 | K140308 | Mastersurg / Expertsurg | Kaltenbach & Voigt GmbH | 2014 | — |
| 0 (this device) | K213139 | SURGmatic S15 L Pro | Kavo Dental GmbH | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 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 EGS? 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 EGS device
- #1 K251869 Disposable Prophy Angle (3399-60, 3399-090…score 10.0 · 1 generation · 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 |
|---|---|---|---|
| * | K140308 | Mastersurg / ExpertsurgSummary page 4…• Product Code: EGS 3. Predicate Device: Predicate Device (Primary): o Proprietary Name: SURGmatic (K140308) o Manufacturer: KaVo Dental GmbH o Common Name: Dental Handpiece, Contr… | 2014 |
| † | K073478 | Supertorque High-Speed Handpieces and Gentlepower Handpieces and Attachements | 2008 |
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 20 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K140308.
How does its category compare?
All EGS devicesEGS Handpiece, Contra- And Right-Angle Attachment, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · EGS
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EGS
189in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EGS
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EGS
82in 2025
MAUDE reports naming product code EGS, 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 | 1 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 1 | — | 0 | 45 |
| 2010 | 2 | — | 0 | 74 |
| 2011 | 3 | 104 | 0 | 2 |
| 2012 | 3 | 288 | 0 | 3 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 38 |
| 2015 | 3 | 245 | 0 | 166 |
| 2016 | 0 | — | 0 | 299 |
| 2017 | 2 | — | 0 | 316 |
| 2018 | 1 | — | 0 | 230 |
| 2019 | 3 | 276 | 0 | 219 |
| 2020 | 1 | — | 0 | 191 |
| 2021 | 1 | — | 0 | 294 |
| 2022 | 4 | 189 | 0 | 279 |
| 2023 | 1 | — | 1 | 115 |
| 2024 | 1 | — | 0 | 81 |
| 2025 | 2 | — | 0 | 82 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SURGmatic S15 L Pro handpiece is intended for:
- Oral, jaw and facial surgery
- Tooth extraction procedures
- Root resection
- Osteotomy
- Removal of carious material
- Tooth, cavity and crown preparations
- Processing of fillings
The SURGmatic S15 L Pro is for use by a trained professional in the field of general dentistry
and/or oral surgery.
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/K213139 · printed Nov 5, 2026
Cite this page
510(k) Report. “K213139: SURGmatic S15 L Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K213139
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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