510(k) · Cleared
Recalled · Class II · 2024Surgical Handpieces, Mikro Saw Handpieces
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W&H Dentalwerk Buermoos GmbH · KMW Handpiece, Rotary Bone Cutting
Cleared on Jul 29, 2008 as substantially equivalent to K011061 (W&H Dentalwerk Buermoos GmbH, 2001) and 1 other predicate after a 117-day review. Its family tree reaches back 2 generations to 2001. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 29, 2008
- Review
- 117 days
- Class
- Class II
- Product code
- KMW
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002469 (2001). 3 ancestors in all. 3 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 deviceK080939 Surgical Handpieces, Mikro Saw HandpiecesW&H Dentalwerk Buermoos GmbH · 2008
- Descendant · cites it directly · 1 of its ownK111532 Montblanc Surgical Contra-Angle and Straight HandpieceAnthogyr Sas · 2011
- Descendant · 2 generations on · 0 of its ownK171155 Surgical Angle Handpiece, Surgical Straight HandpieceNakanishi, Inc. · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK102241 Anthogyr Implanteo Implantology and Dental Surgical Motor UnitAnthogyr Sas · 2011
Most influential descendants
Showing 3 of 3 · See all- K111532Montblanc Surgical Contra-Angle and Straight HandpieceAnthogyr Sas · 2011 · cites it directly1descendant
- K171155Surgical Angle Handpiece, Surgical Straight HandpieceNakanishi, Inc. · 2017 · 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) | K080939 | Surgical Handpieces, Mikro Saw Handpieces | W&H Dentalwerk Buermoos GmbH | 2008 | — |
| +1 | K111532 | Montblanc Surgical Contra-Angle and Straight Handpiece | Anthogyr Sas | 2011 | — |
| +2 | K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece | Nakanishi, Inc. | 2017 | 8 |
| +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 |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K011061 | Surgical Contra-Angel Handpieces Types WS-56E,WS-75E/KM,WS-92 E/3,Surgical Straight…Summary page 1…tion Name Handpiece, rotary bone cutting Regulation Number 21 CFR872.4120 Product Code KMW Predicate Device Surgical contra-angle handpieces, K01 1061 Saw handpieces K052741 Device Description Surgical handpieces and Mikro saw handpieces have… | 2001 |
| * | K052741 | Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl. AccessoriesSummary page 1…ulation Number 21 CFR872.4120 Product Code KMW Predicate Device Surgical contra-angle handpieces, K01 1061 Saw handpieces K052741 Device Description Surgical handpieces and Mikro saw handpieces have been designed to transmit the r… | 2006 |
What descends from it? (3)
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 |
|---|---|---|---|---|
| Jan 16, 2024 | Class II | Z-1168-2024 | Labeling False and Misleading | 1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific laser marking should read 1:2, but instead it reads 1:1 on the body of the handpiece |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 4.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K111532 (Anthogyr Sas, 2011) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K011061.
How does its category compare?
All KMW devicesKMW Handpiece, Rotary Bone Cutting: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Surgical treatment of dental hard tissue in oral and maxillo-facial surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080939 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080939: Surgical Handpieces, Mikro Saw Handpieces.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080939
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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