510(k) · Cleared
ClearedMastersurg / Expertsurg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kaltenbach & Voigt GmbH · EBW Controller, Foot, Handpiece And Cord
Cleared on Aug 15, 2014 as substantially equivalent to K092214 (Bien-Air Dental, SA, 2009) and 1 other predicate after a 189-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Aug 15, 2014
- Review
- 189 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002469 (2001). 5 ancestors in all, the oldest K970953 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK002469 Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V)W&H Dentalwerk Buermoos GmbH · 2001
- 2 generations backK052741 Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version)…W&H Dentalwerk Buermoos GmbH · 2006
- 1 generation backK092214 Chiropro L SystemBien-Air Dental, SA · 2009 · Recalled
- This deviceK140308 Mastersurg / ExpertsurgKaltenbach & Voigt GmbH · 2014
- Descendant · cites it directly · 0 of its ownK213139 SURGmatic S15 L ProKavo Dental GmbH · 2021
- Descendant · cites it directly · 0 of its ownK193341 iCTmotor (WL-1)Dentium Co., Ltd. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002469 | Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V) | W&H Dentalwerk Buermoos GmbH | 2001 | — |
| −2 | K052741 | Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl.… | W&H Dentalwerk Buermoos GmbH | 2006 | — |
| −1 | K092214 | Chiropro L System | Bien-Air Dental, SA | 2009 | 1 |
| 0 (this device) | K140308 | Mastersurg / Expertsurg | Kaltenbach & Voigt GmbH | 2014 | — |
| +1 | K213139 | SURGmatic S15 L Pro | Kavo Dental GmbH | 2021 | — |
| +1 | K193341 | iCTmotor (WL-1) | Dentium Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 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 EBW? 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 EBW device
- #1 K251701 Star E900 Electric Systemscore 12.2 · 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 |
|---|---|---|---|
| * | K092214 | Chiropro L SystemSummary page 4…Dental (EGS) ¢ Classification Name - Dental handpiece and accessories, per 21 CFR § 872.4200 Devices for Which Substantial Equivalence is Claimed: ¢ CHIROPRO L SYSTEM (K092214) marketed by Bien-Air Dental SA SURGICAL STRAIGHT & CONTRA-ANGEL HANDPIECES (K011061) marketed from W & H DENTALWERK BUERMOOS GMB… | 2009 |
| * | K011061 | Surgical Contra-Angel Handpieces Types WS-56E,WS-75E/KM,WS-92 E/3,Surgical Straight…Summary page 4…72.4200 Devices for Which Substantial Equivalence is Claimed: ¢ CHIROPRO L SYSTEM (K092214) marketed by Bien-Air Dental SA SURGICAL STRAIGHT & CONTRA-ANGEL HANDPIECES (K011061) marketed from W & H DENTALWERK BUERMOOS GMBH Device Description: The MASTERsurg / EXPERTsurg is a dental surgical system out o… | 2001 |
What descends from it? (2)
2 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K213139 (Kavo Dental GmbH, 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K092214.
How does its category compare?
All EBW devicesEBW Controller, Foot, Handpiece And Cord: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · EBW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBW
220in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBW
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBW
13in 2025
MAUDE reports naming product code EBW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 5 | 112 | 0 | 16 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 3 | 226 | 0 | 1 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 3 | 189 | 0 | 4 |
| 2015 | 1 | — | 0 | 13 |
| 2016 | 1 | — | 0 | 6 |
| 2017 | 4 | 227 | 0 | 13 |
| 2018 | 1 | — | 0 | 46 |
| 2019 | 2 | — | 0 | 55 |
| 2020 | 1 | — | 0 | 71 |
| 2021 | 2 | — | 0 | 57 |
| 2022 | 6 | 479 | 0 | 31 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 4 | 268 | 0 | 14 |
| 2025 | 3 | 220 | 0 | 13 |
| 2026 | 3 | 269 | 0 | — |
What is it indicated for?
This KaVo product is intended for surgery to expose and dissect oral tissue structures or endodontic treatments (e.g. periodontal gap, gingiva, bone, jaw, extractions and implantations). The medical device is intended to drive / operate a dental handpiece / contra-angle handpiece equipped with a handpiece connection according to ISO 3964. This medical device is an electrical low-voltage motor for dental purposes according to ISO 11498 type 2 and…
Read the full statement (107 words)
This KaVo product is intended for surgery to expose and dissect oral tissue structures or endodontic treatments (e.g. periodontal gap, gingiva, bone, jaw, extractions and implantations).
The medical device is intended to drive / operate a dental handpiece / contra-angle handpiece equipped with a handpiece connection according to ISO 3964. This medical device is an electrical low-voltage motor for dental purposes according to ISO 11498 type 2 and classified as a type B application part.
The medical device is intended for the following uses: Surgery such as setting an implant, bone augmentation, sinus lift, tooth extraction procedures, implantology, osteotomia, root resection and oral, jaw and facial 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/K140308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140308: Mastersurg / Expertsurg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140308
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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