510(k) · Cleared
ClearedPiezotome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Satelec · DZI Drill, Bone, Powered
Cleared on May 1, 2006 as substantially equivalent to K043408 (Piezosurgery S.R.L., 2005) after an 88-day review. Its family tree reaches back 2 generations to 2004. 10 later devices descend from it.
- Decided
- May 1, 2006
- Review
- 88 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042434 (2004). 10 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK042434 Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55Nouvag AG · 2004
- 1 generation backK043408 Piezosurgery DevicePiezosurgery S.R.L. · 2005
- This deviceK060274 PiezotomeSatelec · 2006
- Descendant · cites it directly · 6 of its ownK072146 Ems Piezon Master SurgeryE.M.S Electro Medical Systems S.A · 2007
- Descendant · 2 generations on · 2 of its ownK121620 Ultrasonic SurgeryDmetec.Co., Ltd. · 2012
- Descendant · 2 generations on · 2 of its ownK113152 Ultrasonic Surgery MachineDmetec.Co., Ltd. · 2012
- Descendant · 3 generations on · 1 of its ownK151171 Traus SUS10Saeshin Precision Co., Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK091331 Piezotome 2Satelec · 2009
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K072146Ems Piezon Master SurgeryE.M.S Electro Medical Systems S.A · 2007 · cites it directly6descendants
- K121620Ultrasonic SurgeryDmetec.Co., Ltd. · 2012 · 2 generations on2descendants
- K113152Ultrasonic Surgery MachineDmetec.Co., Ltd. · 2012 · 2 generations on2descendants
- K151171Traus SUS10Saeshin Precision Co., Ltd. · 2015 · 3 generations on1descendant
- K091331Piezotome 2Satelec · 2009 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042434 | Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55 | Nouvag AG | 2004 | — |
| −1 | K043408 | Piezosurgery Device | Piezosurgery S.R.L. | 2005 | — |
| 0 (this device) | K060274 | Piezotome | Satelec | 2006 | — |
| +1 | K072146 | Ems Piezon Master Surgery | E.M.S Electro Medical Systems S.A | 2007 | — |
| +2 | K121620 | Ultrasonic Surgery | Dmetec.Co., Ltd. | 2012 | — |
| +2 | K113152 | Ultrasonic Surgery Machine | Dmetec.Co., Ltd. | 2012 | — |
| +3 | K151171 | Traus SUS10 | Saeshin Precision Co., Ltd. | 2015 | — |
| +1 | K091331 | Piezotome 2 | Satelec | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 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 |
|---|---|---|---|
| * | K043408 | Piezosurgery DeviceSummary page 1…Predicate Device Device Applicant 510(k) No. Date Cleared Piezosurgery® Piezosurgery Srl K043408 June 8, 2005 The Satelec Piezotome T M is substantially equivalent to the predicate device by Piezosurge… | 2005 |
What descends from it? (10)
3 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?
- The line of descent spans 2 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K072146 (E.M.S Electro Medical Systems S.A, 2007) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K043408.
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 PiezotomeTM 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/K060274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060274: Piezotome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060274
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