510(k) · Cleared
ClearedTCM Endo Iii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nouvag AG · EFA Handpiece, Belt And/Or Gear Driven, Dental
Cleared on Nov 28, 2001 after a 65-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Nov 28, 2001
- Review
- 65 days
- Class
- Class I
- Product code
- EFA
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK013185 TCM Endo IiiNouvag AG · 2001
- Descendant · cites it directly · 10 of its ownK031145 Estylus Electric Motor SystemDentsply Intl. · 2003
- Descendant · 2 generations on · 8 of its ownK072989 Axis SystemDentsply Intl., Inc. · 2008
- Descendant · 3 generations on · 7 of its ownK143704 Advanced Air SystemW&H Dentalwerk Buermoos GmbH · 2015
- Descendant · 4 generations on · 6 of its ownK162926 Air-Powered Handpieces and Handpiece AttachmentsW&H Dentalwerk Burmoos GmbH · 2017
- Descendant · 5 generations on · 4 of its ownK181858 Electric Handpiece MotorW&H Dentalwerk Buermoos GmbH · 2019
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K031145Estylus Electric Motor SystemDentsply Intl. · 2003 · cites it directly10descendants
- K072989Axis SystemDentsply Intl., Inc. · 2008 · 2 generations on8descendants
- K143704Advanced Air SystemW&H Dentalwerk Buermoos GmbH · 2015 · 3 generations on7descendants
- K162926Air-Powered Handpieces and Handpiece AttachmentsW&H Dentalwerk Burmoos GmbH · 2017 · 4 generations on6descendants
- K181858Electric Handpiece MotorW&H Dentalwerk Buermoos GmbH · 2019 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013185 | TCM Endo Iii | Nouvag AG | 2001 | — |
| +1 | K031145 | Estylus Electric Motor System | Dentsply Intl. | 2003 | — |
| +2 | K072989 | Axis System | Dentsply Intl., Inc. | 2008 | — |
| +3 | K143704 | Advanced Air System | W&H Dentalwerk Buermoos GmbH | 2015 | — |
| +4 | K162926 | Air-Powered Handpieces and Handpiece Attachments | W&H Dentalwerk Burmoos GmbH | 2017 | — |
| +5 | K181858 | Electric Handpiece Motor | W&H Dentalwerk Buermoos GmbH | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 4 | 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 EFA? 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 EFA device
- #1 K192809 Dental Handpiecescore 3.5 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | — | Quantec-E Endo System Named without a submission number |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031145 | Estylus Electric Motor System | 2003 | 10 |
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, K031145 (Dentsply Intl., 2003) has gone furthest, with 10 descendants of its own.
How does its category compare?
All EFA devicesEFA Handpiece, Belt And/Or Gear Driven, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EFA
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · EFA
78in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EFA
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EFA
4in 2025
MAUDE reports naming product code EFA, 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 | 1 |
| 2008 | 0 | — | 0 | 17 |
| 2009 | 4 | 78 | 0 | 0 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 97 |
| 2019 | 0 | — | 0 | 59 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of the TCM Endo 1lI is to drive dental handpieces during root canal preparation.
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/K013185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013185: TCM Endo Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013185
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026