# K013185: TCM Endo Iii

- Pathway: 510(k) (Traditional)
- Applicant: Nouvag AG
- Decided: Nov 28, 2001 after 65 days
- Product code: EFA (Handpiece, Belt And/Or Gear Driven, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Quantec-E Endo System: named in the summary without a submission number

## Most influential descendants
- K031145: Estylus Electric Motor System (2003), 10 descendants of its own
- K072989: Axis System (2008), 8 descendants of its own
- K143704: Advanced Air System (2015), 7 descendants of its own
- K162926: Air-Powered Handpieces and Handpiece Attachments (2017), 6 descendants of its own
- K181858: Electric Handpiece Motor (2019), 4 descendants of its own

## Indications for use
The intended use of the TCM Endo 1lI is to drive dental handpieces during root canal preparation.

Source page: https://510kreport.com/device/K013185
Methodology: https://510kreport.com/methodology