510(k) · Cleared
ClearedPiezo Bone Surgery
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guilin Woodpecker Medical Instrument Co., Ltd. · DZI Drill, Bone, Powered
Cleared on Nov 18, 2011 as substantially equivalent to K091227 (Piezosurgery S.R.L., 2009) after a 196-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Nov 18, 2011
- Review
- 196 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K896749 (1990). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK896749 Piezon Master 400Electro Medical Systems (Ems Sa) · 1990
- 4 generations backK992504 Ems Kermit(Ems Sa) Electro Medical Systems · 2000
- 3 generations backK022328 Ems Piezon Master 600Electro Medical Systems SA · 2002
- 2 generations backK052518 PiezosurgeryPiezosurgery S.R.L. · 2005
- 1 generation backK091227 Piezosurgery 3; Osstem PiezoPiezosurgery S.R.L. · 2009
- This deviceK111290 Piezo Bone SurgeryGuilin Woodpecker Medical Instrument Co., Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K896749 | Piezon Master 400 | Electro Medical Systems (Ems Sa) | 1990 | — |
| −4 | K992504 | Ems Kermit | (Ems Sa) Electro Medical Systems | 2000 | — |
| −3 | K022328 | Ems Piezon Master 600 | Electro Medical Systems SA | 2002 | — |
| −2 | K052518 | Piezosurgery | Piezosurgery S.R.L. | 2005 | — |
| −1 | K091227 | Piezosurgery 3; Osstem Piezo | Piezosurgery S.R.L. | 2009 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K091227 | Piezosurgery 3; Osstem PiezoSummary page 1…:Drill, bone, powered Classification Name :Bone cutting instrument and accessories 3. Predicate Devices : MECTRON, Piezo Bone Surgery, Piezosurgery, K091 227 Co. LTD. GUILIN… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K091227.
How does its category compare?
All DZI devicesDZI Drill, Bone, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Piezo Bone Surgery is intended for use in the following dental applications:
- Bone culling 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 planning
- Retrograde preparation of root canals
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111290 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111290: Piezo Bone Surgery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111290
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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