510(k) · Cleared
ClearedPiezotome 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Satelec · DZI Drill, Bone, Powered
Cleared on Dec 11, 2009 as substantially equivalent to K060274 (Satelec, 2006) after a 220-day review. Its family tree reaches back 3 generations to 2004. 1 later device descends from it.
- Decided
- Dec 11, 2009
- Review
- 220 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K042434 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK042434 Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55Nouvag AG · 2004
- 2 generations backK043408 Piezosurgery DevicePiezosurgery S.R.L. · 2005
- 1 generation backK060274 PiezotomeSatelec · 2006
- This deviceK091331 Piezotome 2Satelec · 2009
- Descendant · cites it directly · 0 of its ownK163610 PIEZOTOME M+, PIEZOTOME M+ HandpieceSatalec-Acteon Group · 2017
Most influential descendants
Showing 1 of 1 · See all- K163610PIEZOTOME M+, PIEZOTOME M+ HandpieceSatalec-Acteon Group · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042434 | Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55 | Nouvag AG | 2004 | — |
| −2 | K043408 | Piezosurgery Device | Piezosurgery S.R.L. | 2005 | — |
| −1 | K060274 | Piezotome | Satelec | 2006 | — |
| 0 (this device) | K091331 | Piezotome 2 | Satelec | 2009 | — |
| +1 | K163610 | PIEZOTOME M+, PIEZOTOME M+ Handpiece | Satalec-Acteon Group | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K060274 | PiezotomeSummary page 1…cation of the Predicate Device Device Applicant 510(k) No. Date Cleared PIEZOTOME Satelec K060274 May 1, 2006 The Satelec PIEZOTOME 2 is substantially equivalent to the predicate device by Satelec, the PIEZOTOM… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163610 | PIEZOTOME M+, PIEZOTOME M+ Handpiece | 2017 | 0 |
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 5 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K163610 (Satalec-Acteon Group, 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K060274.
How does its category compare?
All DZI devicesDZI Drill, Bone, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 intended use of the Satelec PIEZOTOME 2 is to supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091331 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091331: Piezotome 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091331
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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