510(k) · Cleared
Cleared29540 Dynasurg Electric Handpiece and Irr. System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Motors, Inc. · EFB Handpiece, Air-Powered, Dental
Cleared on May 15, 1991 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- May 15, 1991
- Review
- 65 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK911068 29540 Dynasurg Electric Handpiece and Irr. SystemMicro Motors, Inc. · 1991
- Descendant · cites it directly · 4 of its ownK991401 Atr 3000, Atr 2000, Implant-ProAdvanced Technology Research (A.T.R.) S.R.P. · 1999
- Descendant · 2 generations on · 3 of its ownK033597 Atr 5000, LC 5000, Implant SystemAdvanced Technology Research (A.T.R.) S.R.L. · 2003
- Descendant · 3 generations on · 1 of its ownK041279 Implanteo Implantology MotorAnthogyr · 2004
- Descendant · 4 generations on · 0 of its ownK102241 Anthogyr Implanteo Implantology and Dental Surgical Motor UnitAnthogyr Sas · 2011
- Descendant · 3 generations on · 0 of its ownK091913 HI Tech Implant, HT Physio ImplantBy Dental Srl · 2009
Most influential descendants
Showing 5 of 5 · See all- K991401Atr 3000, Atr 2000, Implant-ProAdvanced Technology Research (A.T.R.) S.R.P. · 1999 · cites it directly4descendants
- K033597Atr 5000, LC 5000, Implant SystemAdvanced Technology Research (A.T.R.) S.R.L. · 2003 · 2 generations on3descendants
- K041279Implanteo Implantology MotorAnthogyr · 2004 · 3 generations on1descendant
- K102241Anthogyr Implanteo Implantology and Dental Surgical Motor UnitAnthogyr Sas · 2011 · 4 generations on0descendants
- K091913HI Tech Implant, HT Physio ImplantBy Dental Srl · 2009 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911068 | 29540 Dynasurg Electric Handpiece and Irr. System | Micro Motors, Inc. | 1991 | — |
| +1 | K991401 | Atr 3000, Atr 2000, Implant-Pro | Advanced Technology Research (A.T.R.) S.R.P. | 1999 | — |
| +2 | K033597 | Atr 5000, LC 5000, Implant System | Advanced Technology Research (A.T.R.) S.R.L. | 2003 | — |
| +3 | K041279 | Implanteo Implantology Motor | Anthogyr | 2004 | — |
| +4 | K102241 | Anthogyr Implanteo Implantology and Dental Surgical Motor Unit | Anthogyr Sas | 2011 | — |
| +3 | K091913 | HI Tech Implant, HT Physio Implant | By Dental Srl | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EFB? 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 EFB device
- #1 K262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED…score 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991401 | Atr 3000, Atr 2000, Implant-Pro | 1999 | 4 |
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?
- Of its descendants, K991401 (Advanced Technology Research (A.T.R.) S.R.P., 1999) has gone furthest, with 4 descendants of its own.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EFB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EFB
209in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EFB
No recall names EFB since 2007.
Adverse event reports per year · EFB
83in 2025
MAUDE reports naming product code EFB, 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 | 12 | 61 | 0 | 13 |
| 2008 | 7 | 97 | 0 | 19 |
| 2009 | 11 | 120 | 0 | 40 |
| 2010 | 8 | 116 | 0 | 78 |
| 2011 | 4 | 168 | 0 | 96 |
| 2012 | 8 | 130 | 0 | 97 |
| 2013 | 3 | 207 | 0 | 61 |
| 2014 | 7 | 200 | 0 | 73 |
| 2015 | 7 | 296 | 0 | 87 |
| 2016 | 3 | 205 | 0 | 122 |
| 2017 | 7 | 246 | 0 | 153 |
| 2018 | 3 | 210 | 0 | 81 |
| 2019 | 3 | 348 | 0 | 117 |
| 2020 | 5 | 259 | 0 | 94 |
| 2021 | 2 | — | 0 | 123 |
| 2022 | 5 | 430 | 0 | 157 |
| 2023 | 4 | 158 | 0 | 116 |
| 2024 | 5 | 209 | 0 | 104 |
| 2025 | 1 | — | 0 | 83 |
| 2026 | 4 | 252 | 0 | — |
https://510kreport.com/device/K911068 · printed Nov 4, 2026
Cite this page
510(k) Report. “K911068: 29540 Dynasurg Electric Handpiece and Irr. System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K911068
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026