510(k) · Cleared
ClearedPiezosurgery 3; Osstem Piezo
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 Dec 29, 2009 as substantially equivalent to K052518 (Piezosurgery S.R.L., 2005) after a 245-day review. Its family tree reaches back 4 generations to 1990. 5 later devices descend from it.
- Decided
- Dec 29, 2009
- Review
- 245 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K896749 (1990). 6 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK896749 Piezon Master 400Electro Medical Systems (Ems Sa) · 1990
- 3 generations backK992504 Ems Kermit(Ems Sa) Electro Medical Systems · 2000
- 2 generations backK022328 Ems Piezon Master 600Electro Medical Systems SA · 2002
- 1 generation backK052518 PiezosurgeryPiezosurgery S.R.L. · 2005
- This deviceK091227 Piezosurgery 3; Osstem PiezoPiezosurgery S.R.L. · 2009
- Descendant · cites it directly · 3 of its ownK102218 Compact Piezo P2K, PowercareMectron S.P.A. · 2011
- Descendant · 2 generations on · 2 of its ownK140965 Multipiezo Pro, MultipiezoMectron S.P.A. · 2014
- Descendant · 3 generations on · 0 of its ownK223173 Proxeo ULTRA (PB-510, PB-520 and PB-530)W&H Dentalwerk Buermoss GmbH · 2023
- Descendant · 2 generations on · 0 of its ownK151023 Compact Piezo LedMectron S.P.A. · 2015
- Descendant · cites it directly · 0 of its ownK111290 Piezo Bone SurgeryGuilin Woodpecker Medical Instrument Co., Ltd. · 2011
Most influential descendants
Showing 5 of 5 · See all- K102218Compact Piezo P2K, PowercareMectron S.P.A. · 2011 · cites it directly3descendants
- K140965Multipiezo Pro, MultipiezoMectron S.P.A. · 2014 · 2 generations on2descendants
- K223173Proxeo ULTRA (PB-510, PB-520 and PB-530)W&H Dentalwerk Buermoss GmbH · 2023 · 3 generations on0descendants
- K151023Compact Piezo LedMectron S.P.A. · 2015 · 2 generations on0descendants
- K111290Piezo Bone SurgeryGuilin Woodpecker Medical Instrument Co., Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K896749 | Piezon Master 400 | Electro Medical Systems (Ems Sa) | 1990 | — |
| −3 | K992504 | Ems Kermit | (Ems Sa) Electro Medical Systems | 2000 | — |
| −2 | K022328 | Ems Piezon Master 600 | Electro Medical Systems SA | 2002 | — |
| −1 | K052518 | Piezosurgery | Piezosurgery S.R.L. | 2005 | — |
| 0 (this device) | K091227 | Piezosurgery 3; Osstem Piezo | Piezosurgery S.R.L. | 2009 | — |
| +1 | K102218 | Compact Piezo P2K, Powercare | Mectron S.P.A. | 2011 | — |
| +2 | K140965 | Multipiezo Pro, Multipiezo | Mectron S.P.A. | 2014 | — |
| +3 | K223173 | Proxeo ULTRA (PB-510, PB-520 and PB-530) | W&H Dentalwerk Buermoss GmbH | 2023 | — |
| +2 | K151023 | Compact Piezo Led | Mectron S.P.A. | 2015 | — |
| +1 | K111290 | Piezo Bone Surgery | Guilin Woodpecker Medical Instrument Co., Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K052518 | PiezosurgerySummary page 2…Via Partobello, 12 - 16039 Sestri Levante, Italy Tel:+39 0185 450863, Fax:+39 0185 42799 E-mail: [email protected] 7. Predicate device Piezosurgery® device (K052518). 8. Performance evaluations The device uses piezoelectric ultrasonic technology to generate mechanical microvibrations of inser… | 2005 |
What descends from it? (5)
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)
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 19 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K102218 (Mectron S.P.A., 2011) has gone furthest, with 3 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. 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 Piezosurgery 3 is intended for use in the following dental applications:
- Bone cutting for use in oral surgery
- Removing supra and subgingival calculus deposits and stains from teeth
- Periodontal pocket lavage with simultaneous ultrasonic tip movement
- Scaling and root planing
- Retrograde preparation of root canals
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K091227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091227: Piezosurgery 3; Osstem Piezo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091227
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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