510(k) · Cleared
ClearedSurgic Pro, Surgic Pro+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nakanishi, Inc. · EBW Controller, Foot, Handpiece And Cord
Cleared on Jun 19, 2018 as substantially equivalent to K161957 (W&H Dentalwerk Burmoos GmbH, 2016) after a 179-day review. Its family tree reaches back 3 generations to 2001. 5 later devices descend from it.
- Decided
- Jun 19, 2018
- Review
- 179 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002469 (2001). 5 later devices descend from it, 4 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 backK161957 W&H Implantmed SI-1015 incl. AccessoriesW&H Dentalwerk Burmoos GmbH · 2016
- This deviceK173905 Surgic Pro, Surgic Pro+Nakanishi, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK201192 Impla-NX (Model: ISE-270M)Micro-Nx Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK231562 ELEC ENGINE (Model: ISE-170L)Micro-Nx Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK233117 Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)Nakanishi, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK220831 Dental Implantation Systems, Dental Electrical MotorsFoshan Coxo Medical Instrument Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK211584 Oral Surgery ContraNakanishi, Inc. · 2021
Most influential descendants
Showing 5 of 5 · See all- K201192Impla-NX (Model: ISE-270M)Micro-Nx Co., Ltd. · 2021 · cites it directly1descendant
- K231562ELEC ENGINE (Model: ISE-170L)Micro-Nx Co., Ltd. · 2025 · 2 generations on0descendants
- K233117Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)Nakanishi, Inc. · 2024 · cites it directly0descendants
- K220831Dental Implantation Systems, Dental Electrical MotorsFoshan Coxo Medical Instrument Co., Ltd. · 2022 · cites it directly0descendants
- K211584Oral Surgery ContraNakanishi, Inc. · 2021 · cites it directly0descendants
View 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 | K161957 | W&H Implantmed SI-1015 incl. Accessories | W&H Dentalwerk Burmoos GmbH | 2016 | — |
| 0 (this device) | K173905 | Surgic Pro, Surgic Pro+ | Nakanishi, Inc. | 2018 | — |
| +1 | K201192 | Impla-NX (Model: ISE-270M) | Micro-Nx Co., Ltd. | 2021 | — |
| +2 | K231562 | ELEC ENGINE (Model: ISE-170L) | Micro-Nx Co., Ltd. | 2025 | — |
| +1 | K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) | Nakanishi, Inc. | 2024 | — |
| +1 | K220831 | Dental Implantation Systems, Dental Electrical Motors | Foshan Coxo Medical Instrument Co., Ltd. | 2022 | — |
| +1 | K211584 | Oral Surgery Contra | Nakanishi, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K161957 | W&H Implantmed SI-1015 incl. AccessoriesSummary page 4…tal handpiece and accessories. Regulation: 21 CFR 872.4120 Class II Product Code: EBW, KMW, EGS Predicate Device: K161957 W&H Implantmed SI-1015 Device Description: The Surgic Pro+ / Surgic Pro consists of the Control Unit, the… | 2016 |
What descends from it? (5)
4 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 17 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K201192 (Micro-Nx Co., Ltd., 2021) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K161957.
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. 2018, 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?
Surgic Pro+ / Surgic Pro
The Surgic Pro+ / Surgic Pro 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.
SG20/ X-SG20L
This medical device is for oral surgery and dental implant operation.
This device is driven by an electronic micromotor for oral surgery and dental implant. The device is intended to transmit the rotation of the power source at different gear ratios, thereby moving instruments such as surgical burs or surgical drills to cut the maxilla / mandible during oral surgery and dental implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173905: Surgic Pro, Surgic Pro+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173905
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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