510(k) · Cleared
Recalled · Class II · 2018Surgical Angle Handpiece, Surgical Straight Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nakanishi, Inc. · KMW Handpiece, Rotary Bone Cutting
Cleared on Nov 21, 2017 as substantially equivalent to K111532 (Anthogyr Sas, 2011) and 1 other predicate after a 215-day review. Its family tree reaches back 6 generations to 1997. It has been recalled 8 times.
- Decided
- Nov 21, 2017
- Review
- 215 days
- Class
- Class II
- Product code
- KMW
- Recalls
- 8
- Predicates
- 2
Its longest line of descent runs back 6 generations to K971350 (1997). 12 ancestors in all, the oldest K970953 (1997). No later device cites it as a predicate yet.
- Root · 6 generations backK971350 Series XE, Series SE, Series TEMicro-Mega Societe Anonyme · 1997
- 5 generations backK040674 Implantology Contra Angles, Endodontic Contra Angles, General…Anthogyr · 2004
- 4 generations backK060317 Anthogyr Contra Angles and HandpiecesEst. Anthogyr · 2006
- 3 generations backK070084 Montblanc Implantology Contra Angle ControlEst. Anthogyr · 2007
- 2 generations backK090676 Montblanc Implantology and Omnipratique Contra-AnglesAnthogyr · 2009
- 1 generation backK111532 Montblanc Surgical Contra-Angle and Straight HandpieceAnthogyr Sas · 2011
- This deviceK171155 Surgical Angle Handpiece, Surgical Straight HandpieceNakanishi, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K971350 | Series XE, Series SE, Series TE | Micro-Mega Societe Anonyme | 1997 | — |
| −5 | K040674 | Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra… | Anthogyr | 2004 | — |
| −4 | K060317 | Anthogyr Contra Angles and Handpieces | Est. Anthogyr | 2006 | — |
| −3 | K070084 | Montblanc Implantology Contra Angle Control | Est. Anthogyr | 2007 | — |
| −2 | K090676 | Montblanc Implantology and Omnipratique Contra-Angles | Anthogyr | 2009 | — |
| −1 | K111532 | Montblanc Surgical Contra-Angle and Straight Handpiece | Anthogyr Sas | 2011 | — |
| 0 (this device) | K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece | Nakanishi, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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 KMW? 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 KMW device
- #1 K211584 Oral Surgery Contrascore 2.8 · 4 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K111532 | Montblanc Surgical Contra-Angle and Straight HandpieceSummary page 4…ument and Accessories Regulation: 21 CFR 872.4120 Class II Product Code: KMW and EGS Predicate Devices: Primary: K111532 Anthogyr SAS MontBlanc Surgical Contra-Angle Secondary: K970953 N… | 2011 |
| * | K970953 | E-Type Speed Reducer Contra AngleSummary page 4…KMW and EGS Predicate Devices: Primary: K111532 Anthogyr SAS MontBlanc Surgical Contra-Angle Secondary: K970953 NAKANISHI INC. Handpiece and Straight Handpiece… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 1, 2018 | Class II | Z-0220-2019 | Device Design | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The previous operation manuals associated with the SGS/SGA products… |
| Jun 1, 2018 | Class II | Z-0222-2019 | Device Design | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products… |
| Jun 1, 2018 | Class II | Z-0225-2019 | Device Design | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products… |
| Jun 1, 2018 | Class II | Z-0224-2019 | Device Design | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products… |
| Jun 1, 2018 | Class II | Z-0219-2019 | Device Design | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The previous operation manuals associated with the SGS/SGA products… |
| Jun 1, 2018 | Class II | Z-0221-2019 | Device Design | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The previous operation manuals associated with the SGS/SGA products… |
| Jun 1, 2018 | Class II | Z-0223-2019 | Device Design | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products… |
| Jun 1, 2018 | Class II | Z-0226-2019 | Device Design | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products… |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 12 ancestors has a recall of any class.
How does its category compare?
All KMW devicesKMW Handpiece, Rotary Bone Cutting: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · KMW
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · KMW
Too few KMW 510(k)s in any year since 2007 to give a median.
Recalls per year · KMW
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMW
22in 2025
MAUDE reports naming product code KMW, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 27 |
| 2016 | 0 | — | 0 | 13 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 0 | — | 8 | 16 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 1 | — | 1 | 32 |
| 2022 | 0 | — | 0 | 54 |
| 2023 | 0 | — | 0 | 25 |
| 2024 | 0 | — | 0 | 49 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Surgical Straight/Angle Handpiece Series is intended for use by licensed professionals for oral surgical and dental use. Typical uses include sectioning and removal of wisdom teeth, cutting teeth, oral surgery (such as root tip resection, bone removal, bone shaping) and implant treatment (such as drilling the maxilla and mandible).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171155: Surgical Angle Handpiece, Surgical Straight Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171155
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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