510(k) · Cleared
ClearedAtr 5000, LC 5000, Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Technology Research (A.T.R.) S.R.L. · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Nov 25, 2003 as substantially equivalent to K991401 (Advanced Technology Research (A.T.R.) S.R.P., 1999) after an 11-day review. Its family tree reaches back 2 generations to 1991. 3 later devices descend from it.
- Decided
- Nov 25, 2003
- Review
- 11 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K911068 (1991). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK911068 29540 Dynasurg Electric Handpiece and Irr. SystemMicro Motors, Inc. · 1991
- 1 generation backK991401 Atr 3000, Atr 2000, Implant-ProAdvanced Technology Research (A.T.R.) S.R.P. · 1999
- This deviceK033597 Atr 5000, LC 5000, Implant SystemAdvanced Technology Research (A.T.R.) S.R.L. · 2003
- Descendant · cites it directly · 1 of its ownK041279 Implanteo Implantology MotorAnthogyr · 2004
- Descendant · 2 generations on · 0 of its ownK102241 Anthogyr Implanteo Implantology and Dental Surgical Motor UnitAnthogyr Sas · 2011
- Descendant · cites it directly · 0 of its ownK091913 HI Tech Implant, HT Physio ImplantBy Dental Srl · 2009
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K033597 | Atr 5000, LC 5000, Implant System | Advanced Technology Research (A.T.R.) S.R.L. | 2003 | — |
| +1 | K041279 | Implanteo Implantology Motor | Anthogyr | 2004 | — |
| +2 | K102241 | Anthogyr Implanteo Implantology and Dental Surgical Motor Unit | Anthogyr Sas | 2011 | — |
| +1 | K091913 | HI Tech Implant, HT Physio Implant | By Dental Srl | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K991401 | Atr 3000, Atr 2000, Implant-ProSummary page 1…ICATION OF PREDICATE DEVICE Company Device 5 lo&) NO. Date Cleared ATR ATR3000 K99 1401 15 Dec. 1999 14.4 DEVICE DESCRIPTION The ATR Surgical Micromotors ATR5000, LC5000 and Implant System… | 1999 |
What descends from it? (3)
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 12 years and passes through 3 companies; a new generation was cleared every 8.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K041279 (Anthogyr, 2004) has gone furthest, with 1 descendant of its own.
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?
These ATR Surgical Micromotors are intended to prepare Intraoral bone for implantology procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033597 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033597: Atr 5000, LC 5000, Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033597
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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