510(k) · Cleared
Recalled · Class II · 2013Chiropro L System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bien-Air Dental, SA · EBW Controller, Foot, Handpiece And Cord
Cleared on Dec 15, 2009 as substantially equivalent to K052741 (W&H Dentalwerk Buermoos GmbH, 2006) and 2 other predicates after a 146-day review. Its family tree reaches back 2 generations to 2001. 4 later devices descend from it. It has been recalled once.
- Decided
- Dec 15, 2009
- Review
- 146 days
- Class
- Class I
- Product code
- EBW
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002469 (2001). 4 ancestors in all, the oldest K970953 (1997). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK002469 Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V)W&H Dentalwerk Buermoos GmbH · 2001
- 1 generation backK052741 Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version)…W&H Dentalwerk Buermoos GmbH · 2006
- This deviceK092214 Chiropro L SystemBien-Air Dental, SA · 2009
- Descendant · cites it directly · 2 of its ownK140308 Mastersurg / ExpertsurgKaltenbach & Voigt GmbH · 2014
- Descendant · 2 generations on · 0 of its ownK213139 SURGmatic S15 L ProKavo Dental GmbH · 2021
- Descendant · 2 generations on · 0 of its ownK193341 iCTmotor (WL-1)Dentium Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK102241 Anthogyr Implanteo Implantology and Dental Surgical Motor UnitAnthogyr Sas · 2011
Most influential descendants
Showing 4 of 4 · See all- K140308Mastersurg / ExpertsurgKaltenbach & Voigt GmbH · 2014 · cites it directly2descendants
- K213139SURGmatic S15 L ProKavo Dental GmbH · 2021 · 2 generations on0descendants
- K193341iCTmotor (WL-1)Dentium Co., Ltd. · 2020 · 2 generations on0descendants
- K102241Anthogyr Implanteo Implantology and Dental Surgical Motor UnitAnthogyr Sas · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002469 | Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V) | W&H Dentalwerk Buermoos GmbH | 2001 | — |
| −1 | K052741 | Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl.… | W&H Dentalwerk Buermoos GmbH | 2006 | — |
| 0 (this device) | K092214 | Chiropro L System | Bien-Air Dental, SA | 2009 | — |
| +1 | K140308 | Mastersurg / Expertsurg | Kaltenbach & Voigt GmbH | 2014 | — |
| +2 | K213139 | SURGmatic S15 L Pro | Kavo Dental GmbH | 2021 | — |
| +2 | K193341 | iCTmotor (WL-1) | Dentium Co., Ltd. | 2020 | — |
| +1 | K102241 | Anthogyr Implanteo Implantology and Dental Surgical Motor Unit | Anthogyr Sas | 2011 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K052741 | Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl. AccessoriesSummary page 1…ct Code EBW) under 2lCFR 872.4200, dental handpiece and accessories 3. PREDICATE DEVICES * implantMED SI-915/923, W & H Dentalwerk, K052741 * TI-Max-SG2OL, NSK NakanishilInc., K970953 * WS-75 E/KM (W & HDentaiwerk Buermoos GmbH, K0l1061) 4. INTENDED USE T… | 2006 |
| * | K970953 | E-Type Speed Reducer Contra AngleSummary page 1…der 2lCFR 872.4200, dental handpiece and accessories 3. PREDICATE DEVICES * implantMED SI-915/923, W & H Dentalwerk, K052741 * TI-Max-SG2OL, NSK NakanishilInc., K970953 * WS-75 E/KM (W & HDentaiwerk Buermoos GmbH, K0l1061) 4. INTENDED USE The Chiropro L system is intended for use in dent… | 1997 |
| * | K011061 | Surgical Contra-Angel Handpieces Types WS-56E,WS-75E/KM,WS-92 E/3,Surgical Straight… | 2001 |
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 24, 2013 | Class II | Z-0273-2014 | Software Manufacturing/Software Deployment | The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with the OseeoCare Pro iPad application software release 1.2.0.7. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K140308 (Kaltenbach & Voigt GmbH, 2014) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K052741.
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. 2009, 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?
The Chiropro L system is intended for use in dental surgery, endlodontics, and implantology. The main unit is designed to be used with a specific dental micromnotor that drives dental handpieces fitted with appropriate tools to cut hard and soft tissues in the mouth and to screw dental implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092214 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092214: Chiropro L System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092214
Report an extraction error
Are you the manufacturer?
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