510(k) · Cleared
ClearedUltrasonic Surgery Machine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dmetec.Co., Ltd. · DZI Drill, Bone, Powered
Cleared on Jun 14, 2012 as substantially equivalent to K072146 (E.M.S Electro Medical Systems S.A, 2007) after a 233-day review. Its family tree reaches back 4 generations to 2004. 2 later devices descend from it.
- Decided
- Jun 14, 2012
- Review
- 233 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K042434 (2004). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK042434 Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55Nouvag AG · 2004
- 3 generations backK043408 Piezosurgery DevicePiezosurgery S.R.L. · 2005
- 2 generations backK060274 PiezotomeSatelec · 2006
- 1 generation backK072146 Ems Piezon Master SurgeryE.M.S Electro Medical Systems S.A · 2007
- This deviceK113152 Ultrasonic Surgery MachineDmetec.Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK192033 Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip…Bennett Jacoby, Dds, Ms, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK131674 Prebent Plating with Virtual Surgical PlanningBiomet Microfixation · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K042434 | Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55 | Nouvag AG | 2004 | — |
| −3 | K043408 | Piezosurgery Device | Piezosurgery S.R.L. | 2005 | — |
| −2 | K060274 | Piezotome | Satelec | 2006 | — |
| −1 | K072146 | Ems Piezon Master Surgery | E.M.S Electro Medical Systems S.A | 2007 | — |
| 0 (this device) | K113152 | Ultrasonic Surgery Machine | Dmetec.Co., Ltd. | 2012 | — |
| +1 | K192033 | Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour… | Bennett Jacoby, Dds, Ms, Inc. | 2020 | — |
| +1 | K131674 | Prebent Plating with Virtual Surgical Planning | Biomet Microfixation | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K072146 | Ems Piezon Master SurgerySummary page 1…3) Model Number(s): Surgy Star, AIC SURGERY 4) Classification Name: Drill, Bone, Powered 5) Regulation Number: 872.4120 Predicate Device Information 1) 510(k) Number: K072146 2) Trade Name: EMS Piezon Master Surgery 3) Product Code: DZI Description of the Device This product is a device using by purpos… | 2007 |
What descends from it? (2)
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 8 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K192033 (Bennett Jacoby, Dds, Ms, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K072146.
How does its category compare?
All DZI devicesDZI Drill, Bone, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
A device intended for use surgical procedure Including osteotomy, osteoplasty, Periodontal surgery and implantation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113152 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113152: Ultrasonic Surgery Machine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113152
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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