510(k) · Cleared
ClearedSonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L
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 Jun 2, 2015 as substantially equivalent to K110881 (Dong IL Technology, Ltd., 2011) after a 139-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Jun 2, 2015
- Review
- 139 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K042434 (2004). No later device cites it as a predicate yet.
- Root · 3 generations backK042434 Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55Nouvag AG · 2004
- 2 generations backK043408 Piezosurgery DevicePiezosurgery S.R.L. · 2005
- 1 generation backK110881 Ultrasonic Surgical UnitDong IL Technology, Ltd. · 2011
- This deviceK150076 Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800LDong IL Technology, Ltd. · 2015
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 | K110881 | Ultrasonic Surgical Unit | Dong IL Technology, Ltd. | 2011 | — |
| 0 (this device) | K150076 | Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L | Dong IL Technology, Ltd. | 2015 | — |
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 |
|---|---|---|---|
| * | K110881 | Ultrasonic Surgical UnitSummary page 4…nal communicating device Contact: Tissue/bone/dentin Contact duration: Limited exposure (A) D. legally marketed predicate devices: Primary: Sonic Surgeon 300 (K110881) Reference: UBS ultrasonic bone surgery and UDD ultrasonic debridement device (K080220) E. Device Description: Sonic Surgeo… | 2011 |
| † | K080220 | Piezo Ultrasonic Device, Model Ultrasonic Bone Surgery; Ultrasonic Debridment Device | 2008 |
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 11 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All DZI devicesDZI Drill, Bone, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L are piezoelectric devices for surgery that enable
mechanical ultrasound treatment, osteotomy and osteoplasty techniques to be applied in dental use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150076: Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150076
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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