510(k) · Cleared
ClearedPiezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W&H Dentalwerk Buermoos GmbH · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Jul 3, 2025 as substantially equivalent to K153743 (Mectron S.P.A., 2016) after a 259-day review. Its family tree reaches back 9 generations to 1986. 1 of the 32 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 3, 2025
- Review
- 259 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K862807 (1986). 31 ancestors in all, the oldest K801623 (1980). No later device cites it as a predicate yet. 1 of the 32 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 5 generations between
- 3 generations backK100410 Piezoelectric SystemSatelec · 2010
- 2 generations backK132848 Piezosurgery FlexMectron S.P.A. · 2013
- 1 generation backK153743 Piezosurgery PlusMectron S.P.A. · 2016
- This deviceK243280 Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350…W&H Dentalwerk Buermoos GmbH · 2025
Show all 9 generations
- Root · 9 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 8 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 7 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 6 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 5 generations backK990524 E9000 SystemLinvatec Corp. · 1999
- 4 generations backK083284 Piezosurgery MedicalPiezosurgery S.R.L. · 2009
- 3 generations backK100410 Piezoelectric SystemSatelec · 2010
- 2 generations backK132848 Piezosurgery FlexMectron S.P.A. · 2013
- 1 generation backK153743 Piezosurgery PlusMectron S.P.A. · 2016
- This deviceK243280 Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350…W&H Dentalwerk Buermoos GmbH · 2025
Class I recalls in this family
- K043310 Synthes (Usa) Electric Pen Drive System4 generations back · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −8 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −7 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −6 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −5 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| −4 | K083284 | Piezosurgery Medical | Piezosurgery S.R.L. | 2009 | — |
| −3 | K100410 | Piezoelectric System | Satelec | 2010 | — |
| −2 | K132848 | Piezosurgery Flex | Mectron S.P.A. | 2013 | — |
| −1 | K153743 | Piezosurgery Plus | Mectron S.P.A. | 2016 | — |
| 0 (this device) | K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed… | W&H Dentalwerk Buermoos GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 1 |
| 2007 | 2 | 0 |
| 2009 | 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.
1 device in this family has a Class I recall. 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 ERL device
- #1 K233958 hekaDrillscore 9.1 · 8 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.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K043310Synthes (Usa) Electric Pen Drive SystemSynthes (Usa) · 2005 · 4 generations back · ◆ in the 2005 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 39 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 31 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K153743.
How does its category compare?
All ERL devicesERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · ERL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ERL
191in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ERL
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ERL
1,469in 2025
MAUDE reports naming product code ERL, 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 | 112 |
| 2008 | 6 | 181 | 0 | 60 |
| 2009 | 1 | — | 1 | 249 |
| 2010 | 0 | — | 0 | 444 |
| 2011 | 0 | — | 0 | 1,068 |
| 2012 | 2 | — | 0 | 1,379 |
| 2013 | 2 | — | 3 | 3,231 |
| 2014 | 1 | — | 0 | 1,975 |
| 2015 | 3 | 86 | 0 | 2,630 |
| 2016 | 4 | 180 | 0 | 1,455 |
| 2017 | 2 | — | 0 | 999 |
| 2018 | 1 | — | 0 | 1,380 |
| 2019 | 1 | — | 0 | 2,515 |
| 2020 | 1 | — | 5 | 2,369 |
| 2021 | 1 | — | 1 | 2,283 |
| 2022 | 3 | 191 | 0 | 1,574 |
| 2023 | 0 | — | 0 | 1,725 |
| 2024 | 1 | — | 0 | 1,588 |
| 2025 | 1 | — | 0 | 1,469 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The piezoelectric surgical system is indicated for: osteotomies, osteoplasties, drilling and shaping of hard tissue. Including:
- Otolaryngology,
- Maxillofacial surgery,
- hand- & foot-surgery and
- plastic & reconstructive surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243280 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243280: Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243280
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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