510(k) · Cleared
ClearedSurgical Contra-Angel Handpieces Types WS-56E,WS-75E/KM,WS-92 E/3,Surgical Straight Handpieces Types, S-9, S-10, S-11
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W&H Dentalwerk Buermoos GmbH · EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Cleared on Jun 28, 2001 after an 83-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 25 later devices descend from it.
- Decided
- Jun 28, 2001
- Review
- 83 days
- Class
- Class I
- Product code
- EGS
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 10 citing it directly.
- This deviceK011061 Surgical Contra-Angel Handpieces Types WS-56E,WS-75E/KM,WS-92…W&H Dentalwerk Buermoos GmbH · 2001
- Descendant · cites it directly · 4 of its ownK123695 Traus SIP10Saeshin Precision Co., Ltd. · 2012
- Descendant · cites it directly · 4 of its ownK112305 Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle…Thunder Tiger Corp. · 2012
- Descendant · cites it directly · 4 of its ownK092214 Chiropro L SystemBien-Air Dental, SA · 2009 · Recalled
- Descendant · 2 generations on · 3 of its ownK141886 MDK HandpiecesModern Korea Co., Ltd. · 2015
- Descendant · cites it directly · 3 of its ownK100192 Strong Dental HandpiecesSaeshin Precision Co., Ltd. · 2010
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K123695Traus SIP10Saeshin Precision Co., Ltd. · 2012 · cites it directly4descendants
- K112305Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle Handpieces, Vigor S Low…Thunder Tiger Corp. · 2012 · cites it directly4descendants
- K092214Chiropro L SystemBien-Air Dental, SA · 2009 · cites it directly4descendants
- K141886MDK HandpiecesModern Korea Co., Ltd. · 2015 · 2 generations on3descendants
- K100192Strong Dental HandpiecesSaeshin Precision Co., Ltd. · 2010 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011061 | Surgical Contra-Angel Handpieces Types WS-56E,WS-75E/KM,WS-92 E/3,Surgical… | W&H Dentalwerk Buermoos GmbH | 2001 | — |
| +1 | K123695 | Traus SIP10 | Saeshin Precision Co., Ltd. | 2012 | — |
| +1 | K112305 | Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle Handpieces, Vigor… | Thunder Tiger Corp. | 2012 | — |
| +1 | K092214 | Chiropro L System | Bien-Air Dental, SA | 2009 | 1 |
| +2 | K141886 | MDK Handpieces | Modern Korea Co., Ltd. | 2015 | — |
| +1 | K100192 | Strong Dental Handpieces | Saeshin Precision Co., Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (25)
See all 2510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123695 | Traus SIP10 | 2012 | 4 |
| K112305 | Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle Handpieces, Vigor S Low… | 2012 | 4 |
| K092214 | Chiropro L System | 2009 | 4 |
| K100192 | Strong Dental Handpieces | 2010 | 3 |
| K080939 | Surgical Handpieces, Mikro Saw Handpieces | 2008 | 3 |
| K140308 | Mastersurg / Expertsurg | 2014 | 2 |
| K111532 | Montblanc Surgical Contra-Angle and Straight Handpiece | 2011 | 1 |
| K121901 | TI-Max Z45 | 2013 | 0 |
| K051661 | Implant Handpieces | 2005 | 0 |
| K022505 | Contra-Angle, Models 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063… | 2003 | 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?
- Of its descendants, K123695 (Saeshin Precision Co., Ltd., 2012) has gone furthest, with 4 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K011061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011061: Surgical Contra-Angel Handpieces Types WS-56E,WS-75E/KM,WS-92 E/3,Surgical Straight Handpieces Types, S-9, S-10, S-11.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011061
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026