510(k) · Cleared
ClearedDental Bone Cutting Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · DZJ Driver, Wire, And Bone Drill, Manual
Cleared on Jun 23, 2015 as substantially equivalent to K082649 (Synthes (Usa), 2009) after an 89-day review. Its family tree reaches back 1 generation to 2009.
- Decided
- Jun 23, 2015
- Review
- 89 days
- Class
- Class II
- Product code
- DZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082649 (2009). No later device cites it as a predicate yet.
- Root · 1 generation backK082649 Synthes 90 Degree ScrewdriverSynthes (Usa) · 2009
- This deviceK150796 Dental Bone Cutting InstrumentsSynthes (USA) Products, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082649 | Synthes 90 Degree Screwdriver | Synthes (Usa) | 2009 | — |
| 0 (this device) | K150796 | Dental Bone Cutting Instruments | Synthes (USA) Products, LLC | 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 DZJ? 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 DZJ device
- #1 K243637 Materialise Personalized Guides and Models for…score 13.7 · 7 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 |
|---|---|---|---|
| * | K082649 | Synthes 90 Degree ScrewdriverSummary page 4…II Product code: DZJ (Driver, Wire, and Bone Drill Manual) 21 CFR 872.4120 PREDICATE DEVICE Synthes 90° Screwdriver K082649 is the primary predicate. Medtronic Sofamor Danek POWEREASE System K123270 is used as a reference device in support of this subm… | 2009 |
| † | K123270 | Powerease System | 2013 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K082649.
How does its category compare?
All DZJ devicesDZJ Driver, Wire, And Bone Drill, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZJ
142in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZJ
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZJ
14in 2025
MAUDE reports naming product code DZJ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 142 |
| 2010 | 0 | — | 0 | 517 |
| 2011 | 0 | — | 5 | 578 |
| 2012 | 1 | — | 0 | 621 |
| 2013 | 0 | — | 1 | 809 |
| 2014 | 1 | — | 0 | 539 |
| 2015 | 2 | — | 0 | 18 |
| 2016 | 0 | — | 0 | 16 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 2 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 4 |
| 2020 | 4 | 379 | 0 | 17 |
| 2021 | 3 | 403 | 0 | 22 |
| 2022 | 3 | 179 | 0 | 23 |
| 2023 | 3 | 142 | 0 | 22 |
| 2024 | 1 | — | 0 | 13 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Dental Bone Cutting Instruments are nonpowered hand-held devices intended for trauma, reconstruction, or orthognathic procedures to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw.
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/K150796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150796: Dental Bone Cutting Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150796
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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