510(k) · Cleared
ClearedSurgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)
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 20, 2024 as substantially equivalent to K173905 (Nakanishi, Inc., 2018) and 2 other predicates after a 267-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Jun 20, 2024
- Review
- 267 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K990682 (1999). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK990682 Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max)…Nsk Nakanishi, Inc. · 1999
- 3 generations backK092614 X-Smart EasyDentsply Interntional · 2009
- 2 generations backK103653 E3 Torque Control MotorDentsply International, Inc. · 2011
- 1 generation backK161213 XSmart iQDentsply Sirona · 2017
- This deviceK233117 Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)Nakanishi, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K990682 | Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max), Endo-Mate… | Nsk Nakanishi, Inc. | 1999 | — |
| −3 | K092614 | X-Smart Easy | Dentsply Interntional | 2009 | — |
| −2 | K103653 | E3 Torque Control Motor | Dentsply International, Inc. | 2011 | — |
| −1 | K161213 | XSmart iQ | Dentsply Sirona | 2017 | — |
| 0 (this device) | K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) | Nakanishi, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K173905 | Surgic Pro, Surgic Pro+Summary page 5…ber 872.4200 Product Code EBW | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K173905 Surgic Pro+ / Surgic Pro EBW K161957 W&H Implantmed SI-1015 Incl. Accessories EBW K161213 XSmart iQ EBW Device Description Summar… | 2018 |
| * | K161957 | W&H Implantmed SI-1015 incl. AccessoriesSummary page 5…lly Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K173905 Surgic Pro+ / Surgic Pro EBW K161957 W&H Implantmed SI-1015 Incl. Accessories EBW K161213 XSmart iQ EBW Device Description Summary 21 CFR 807.92(a)(4) The Surgic Pro… | 2016 |
| * | K161213 | XSmart iQSummary page 5…edicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K173905 Surgic Pro+ / Surgic Pro EBW K161957 W&H Implantmed SI-1015 Incl. Accessories EBW K161213 XSmart iQ EBW Device Description Summary 21 CFR 807.92(a)(4) The Surgic Pro2 consists of the Control Unit, the Foot Control, Mot… | 2017 |
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 25 years and passes through 5 companies; a new generation was cleared every 7.4 years on median.
- None of the 8 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. 2024, 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 Surgic Pro2 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.
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/K233117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233117: Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233117
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