510(k) · Cleared
ClearedMicropower Hand Piece: Oral Max High Speed Drill
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · DZI Drill, Bone, Powered
Cleared on Apr 10, 2006 as substantially equivalent to K971059 (Linvatec Corp., 1997) after a 68-day review. Its family tree reaches back 3 generations to 1986. 5 later devices descend from it.
- Decided
- Apr 10, 2006
- Review
- 68 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K862807 (1986). 7 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 2 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 1 generation backK971059 Universal Drive SystemLinvatec Corp. · 1997
- This deviceK060270 Micropower Hand Piece: Oral Max High Speed DrillLinvatec Corp. · 2006
- Descendant · cites it directly · 3 of its ownK072706 Microchoice Drills and Saws, Micropower Drills and Saws, Micropower…Conmed Linvatec · 2007
- Descendant · 2 generations on · 1 of its ownK092977 Eberle Shaver System AccessoriesEfs Eberle Feinwerktechnische Systeme · 2010
- Descendant · 3 generations on · 0 of its ownK193608 EBERLE Shaver System C3 and AccessoriesEberle GmbH & Co. KG · 2021
- Descendant · 2 generations on · 0 of its ownK080444 Conmed Linvatec Osprey Drill SystemConmed Linvatec · 2008
- Descendant · cites it directly · 0 of its ownK070233 Conmed Linvatec Smart Guard IrrigatorConmed Linvatec · 2007
Most influential descendants
Showing 5 of 5 · See all- K072706Microchoice Drills and Saws, Micropower Drills and Saws, Micropower Oralmax High Speed…Conmed Linvatec · 2007 · cites it directly3descendants
- K092977Eberle Shaver System AccessoriesEfs Eberle Feinwerktechnische Systeme · 2010 · 2 generations on1descendant
- K193608EBERLE Shaver System C3 and AccessoriesEberle GmbH & Co. KG · 2021 · 3 generations on0descendants
- K080444Conmed Linvatec Osprey Drill SystemConmed Linvatec · 2008 · 2 generations on0descendants
- K070233Conmed Linvatec Smart Guard IrrigatorConmed Linvatec · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −2 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −1 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| 0 (this device) | K060270 | Micropower Hand Piece: Oral Max High Speed Drill | Linvatec Corp. | 2006 | — |
| +1 | K072706 | Microchoice Drills and Saws, Micropower Drills and Saws, Micropower Oralmax… | Conmed Linvatec | 2007 | — |
| +2 | K092977 | Eberle Shaver System Accessories | Efs Eberle Feinwerktechnische Systeme | 2010 | — |
| +3 | K193608 | EBERLE Shaver System C3 and Accessories | Eberle GmbH & Co. KG | 2021 | — |
| +2 | K080444 | Conmed Linvatec Osprey Drill System | Conmed Linvatec | 2008 | — |
| +1 | K070233 | Conmed Linvatec Smart Guard Irrigator | Conmed Linvatec | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K971059 | Universal Drive SystemSummary page 1…g instrument and accessories Proposed Class/Device: Class 1I Product Code: DZI D. Predicate/Legally Marketed Devices K971059 - Universal Dtive System MicroPower Hand Piece: Oral Max High Speed Drill Special 510(k) # K060270 E. Dev… | 1997 |
What descends from it? (5)
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 20 years and passes through 2 companies; a new generation was cleared every 8.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K072706 (Conmed Linvatec, 2007) has gone furthest, with 3 descendants of its own.
- 10 other devices also cite its predicate K971059.
How does its category compare?
All DZI devicesDZI Drill, Bone, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 MicroPower Hand Piece: OralMax High Speed Drill, functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The field of application includes only oral/maxillofacial.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060270 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060270: Micropower Hand Piece: Oral Max High Speed Drill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060270
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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