510(k) · Cleared
ClearedImplanteo Implantology Motor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anthogyr · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Sep 23, 2004 as substantially equivalent to K033597 (Advanced Technology Research (A.T.R.) S.R.L., 2003) and 1 other predicate after a 133-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it.
- Decided
- Sep 23, 2004
- Review
- 133 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K911068 (1991). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK911068 29540 Dynasurg Electric Handpiece and Irr. SystemMicro Motors, Inc. · 1991
- 2 generations backK991401 Atr 3000, Atr 2000, Implant-ProAdvanced Technology Research (A.T.R.) S.R.P. · 1999
- 1 generation backK033597 Atr 5000, LC 5000, Implant SystemAdvanced Technology Research (A.T.R.) S.R.L. · 2003
- This deviceK041279 Implanteo Implantology MotorAnthogyr · 2004
- Descendant · cites it directly · 0 of its ownK102241 Anthogyr Implanteo Implantology and Dental Surgical Motor UnitAnthogyr Sas · 2011
Most influential descendants
Showing 1 of 1 · See all- K102241Anthogyr Implanteo Implantology and Dental Surgical Motor UnitAnthogyr Sas · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911068 | 29540 Dynasurg Electric Handpiece and Irr. System | Micro Motors, Inc. | 1991 | — |
| −2 | K991401 | Atr 3000, Atr 2000, Implant-Pro | Advanced Technology Research (A.T.R.) S.R.P. | 1999 | — |
| −1 | K033597 | Atr 5000, LC 5000, Implant System | Advanced Technology Research (A.T.R.) S.R.L. | 2003 | — |
| 0 (this device) | K041279 | Implanteo Implantology Motor | Anthogyr | 2004 | — |
| +1 | K102241 | Anthogyr Implanteo Implantology and Dental Surgical Motor Unit | Anthogyr Sas | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 EKX? 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 EKX device
- #1 K261987 Reusable SmartPegscore 13.2 · 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? (2)
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 |
|---|---|---|---|
| * | K033597 | Atr 5000, LC 5000, Implant SystemSummary page 2…nstruments - Metallic materials - Part 1 stainless steel EN 1441 (1997) "Medical devices- Risk management" 5 SUBSTANTIAL EQUIVALENCE Predicate devices: K033597 - ATR 5000 Implant system - Advanced Technology Research K030163 -VCT Versatile Control Technology Model AEU -925 - Aseptico… | 2003 |
| * | K030163 | Aseptico VCT Versatile Command Technology Model Aeu-925Summary page 2…EN 1441 (1997) "Medical devices- Risk management" 5 SUBSTANTIAL EQUIVALENCE Predicate devices: K033597 - ATR 5000 Implant system - Advanced Technology Research K030163 -VCT Versatile Control Technology Model AEU -925 - Aseptico IMPLANTEO is substantially equivalent to these predicate devices i… | 2003 |
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 |
|---|---|---|---|
| K102241 | Anthogyr Implanteo Implantology and Dental Surgical Motor Unit | 2011 | 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 13 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K102241 (Anthogyr Sas, 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K033597.
How does its category compare?
All EKX devicesEKX Handpiece, Direct Drive, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EKX
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EKX
244in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EKX
No recall names EKX since 2007.
Adverse event reports per year · EKX
9in 2025
MAUDE reports naming product code EKX, 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 | 1 | — | 0 | 9 |
| 2008 | 3 | 101 | 0 | 10 |
| 2009 | 4 | 186 | 0 | 11 |
| 2010 | 3 | 114 | 0 | 20 |
| 2011 | 4 | 75 | 0 | 6 |
| 2012 | 2 | — | 0 | 27 |
| 2013 | 2 | — | 0 | 45 |
| 2014 | 3 | 251 | 0 | 102 |
| 2015 | 3 | 178 | 0 | 68 |
| 2016 | 3 | 274 | 0 | 66 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 3 | 293 | 0 | 49 |
| 2019 | 3 | 349 | 0 | 56 |
| 2020 | 1 | — | 0 | 67 |
| 2021 | 5 | 214 | 0 | 79 |
| 2022 | 3 | 359 | 0 | 37 |
| 2023 | 4 | 152 | 0 | 14 |
| 2024 | 4 | 276 | 0 | 19 |
| 2025 | 5 | 244 | 0 | 9 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
IMPLANTEO motor is indicated to perform dental implant surgery, such as perforating the bone and taping and threading procedures required before placement of implant prosthetics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041279 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041279: Implanteo Implantology Motor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041279
Report an extraction error
Are you the manufacturer?
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