510(k) · Cleared
ClearedDental Implantation Systems, Dental Electrical Motors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foshan Coxo Medical Instrument Co., Ltd. · EBW Controller, Foot, Handpiece And Cord
Cleared on Sep 27, 2022 as substantially equivalent to K173905 (Nakanishi, Inc., 2018) after a 189-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Sep 27, 2022
- Review
- 189 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002469 (2001). 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 backK161957 W&H Implantmed SI-1015 incl. AccessoriesW&H Dentalwerk Burmoos GmbH · 2016
- 1 generation backK173905 Surgic Pro, Surgic Pro+Nakanishi, Inc. · 2018
- This deviceK220831 Dental Implantation Systems, Dental Electrical MotorsFoshan Coxo Medical Instrument Co., Ltd. · 2022
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 | K161957 | W&H Implantmed SI-1015 incl. Accessories | W&H Dentalwerk Burmoos GmbH | 2016 | — |
| −1 | K173905 | Surgic Pro, Surgic Pro+ | Nakanishi, Inc. | 2018 | — |
| 0 (this device) | K220831 | Dental Implantation Systems, Dental Electrical Motors | Foshan Coxo Medical Instrument Co., Ltd. | 2022 | — |
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? (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 |
|---|---|---|---|
| * | K173905 | Surgic Pro, Surgic Pro+Summary page 6…3-2 510(k) Summary Predicate Device 510(k) Number: K173905 Product Name: Surgic Pro, Surgic Pro+ Manufacturer: NAKANISHI INC. 6. Non-Clinical Test Conclusion Non clini… | 2018 |
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 21 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K173905.
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. 2022, 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?
C-Sailor Pro: This device is intended for use in dental oral surgery and dental implant.The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth. It must only be used in hospital environments, clinics or dental offices by qualified dental personnel. C-PUMA MASTER: The Dental Electrical Motor is intended for use in dental oral surgery and dental…
Read the full statement (119 words)
C-Sailor Pro:
This device is intended for use in dental oral surgery and dental implant.The main unit is designed to be used with a
specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.
It must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
C-PUMA MASTER:
The Dental Electrical Motor is intended for use in dental oral surgery and dental implant. The main unit is designed to be
used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the
mouth.
This device is designed for use by a trained professional in the filed of general dentistry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220831: Dental Implantation Systems, Dental Electrical Motors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220831
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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