510(k) · Cleared
ClearedUltrasonic Surgical Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dong IL Technology, Ltd. · DZI Drill, Bone, Powered
Cleared on Dec 16, 2011 as substantially equivalent to K043408 (Piezosurgery S.R.L., 2005) after a 261-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it.
- Decided
- Dec 16, 2011
- Review
- 261 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042434 (2004). 1 later device descends from it, 1 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 deviceK110881 Ultrasonic Surgical UnitDong IL Technology, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK150076 Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800LDong IL Technology, Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K150076Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800LDong IL Technology, Ltd. · 2015 · cites it directly0descendants
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) | K110881 | Ultrasonic Surgical Unit | Dong IL Technology, Ltd. | 2011 | — |
| +1 | K150076 | Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L | Dong IL Technology, Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 |
|---|---|---|---|
| * | K043408 | Piezosurgery DeviceSummary page 1…surgical instrument and accessories/attachments Regulatory Classification: 2, Dental, Product Code: DZI C. legally marketed predicate devices -Piezosurgel(K043408) D. Device Description, Sonic Surgeon 300is an ultrasound generator for use in dental surgery.And this device… | 2005 |
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 |
|---|---|---|---|
| K150076 | Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L | 2015 | 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 7 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K150076 (Dong IL Technology, Ltd., 2015) has gone furthest, with 0 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. 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?
Ultrasonic Surgical Unit is a piezoelctric device for bone surgery that enables osteotomny and osteoplasty techniques to be applied to in dental use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110881: Ultrasonic Surgical Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110881
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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