510(k) · Cleared
ClearedPiezosurgery Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Piezosurgery S.R.L. · DZI Drill, Bone, Powered
Cleared on Jun 8, 2005 as substantially equivalent to K042434 (Nouvag AG, 2004) after a 180-day review. Its family tree reaches back 1 generation to 2004. 21 later devices descend from it.
- Decided
- Jun 8, 2005
- Review
- 180 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042434 (2004). 21 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK042434 Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55Nouvag AG · 2004
- This deviceK043408 Piezosurgery DevicePiezosurgery S.R.L. · 2005
- Descendant · cites it directly · 10 of its ownK060274 PiezotomeSatelec · 2006
- Descendant · cites it directly · 9 of its ownK083284 Piezosurgery MedicalPiezosurgery S.R.L. · 2009
- Descendant · 2 generations on · 8 of its ownK100410 Piezoelectric SystemSatelec · 2010
- Descendant · 2 generations on · 6 of its ownK132848 Piezosurgery FlexMectron S.P.A. · 2013
- Descendant · cites it directly · 6 of its ownK072146 Ems Piezon Master SurgeryE.M.S Electro Medical Systems S.A · 2007
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K060274PiezotomeSatelec · 2006 · cites it directly10descendants
- K083284Piezosurgery MedicalPiezosurgery S.R.L. · 2009 · cites it directly9descendants
- K100410Piezoelectric SystemSatelec · 2010 · 2 generations on8descendants
- K132848Piezosurgery FlexMectron S.P.A. · 2013 · 2 generations on6descendants
- K072146Ems Piezon Master SurgeryE.M.S Electro Medical Systems S.A · 2007 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042434 | Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55 | Nouvag AG | 2004 | — |
| 0 (this device) | K043408 | Piezosurgery Device | Piezosurgery S.R.L. | 2005 | — |
| +1 | K060274 | Piezotome | Satelec | 2006 | — |
| +1 | K083284 | Piezosurgery Medical | Piezosurgery S.R.L. | 2009 | — |
| +2 | K100410 | Piezoelectric System | Satelec | 2010 | — |
| +2 | K132848 | Piezosurgery Flex | Mectron S.P.A. | 2013 | — |
| +1 | K072146 | Ems Piezon Master Surgery | E.M.S Electro Medical Systems S.A | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 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 DZI? 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 DZI device
- #1 K253776 Implantmed Plus II & Piezomed Plus II Modulescore 12.1 · 3 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 |
|---|---|---|---|
| * | K042434 | Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55Summary page 1…ontics. 6. Intended use: The Piezosurgery device is a bone cutting instrument intended for use in oral surgery. 7. Predicate device: Micro-motor system MD20 Nouvag (K042434) 8. Substantial equivalence comparison: Technical, clinical and histologic comparisons presented in this submission support a… | 2004 |
What descends from it? (21)
See all 215 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?
- Its one ancestor has no recall.
- Of its descendants, K060274 (Satelec, 2006) has gone furthest, with 10 descendants of its own.
How does its category compare?
All DZI devicesDZI Drill, Bone, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZI
300in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZI
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZI
39in 2025
MAUDE reports naming product code DZI, 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 | 2 | — | 0 | 53 |
| 2008 | 4 | 171 | 0 | 45 |
| 2009 | 5 | 220 | 1 | 22 |
| 2010 | 0 | — | 0 | 15 |
| 2011 | 2 | — | 0 | 42 |
| 2012 | 4 | 191 | 0 | 25 |
| 2013 | 0 | — | 0 | 57 |
| 2014 | 1 | — | 0 | 50 |
| 2015 | 3 | 123 | 0 | 39 |
| 2016 | 1 | — | 0 | 43 |
| 2017 | 0 | — | 0 | 38 |
| 2018 | 3 | 290 | 0 | 73 |
| 2019 | 0 | — | 0 | 50 |
| 2020 | 3 | 300 | 0 | 55 |
| 2021 | 0 | — | 0 | 84 |
| 2022 | 0 | — | 0 | 63 |
| 2023 | 1 | — | 0 | 63 |
| 2024 | 2 | — | 0 | 58 |
| 2025 | 1 | — | 0 | 39 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Piezosurgery device is a bone cutting instrument intended for use in oral surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043408 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043408: Piezosurgery Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043408
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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