# K993188: Endostepper 1

- Pathway: 510(k) (Traditional)
- Applicant: Phytron- Elektronik GmbH
- Decided: Sep 28, 1999 after 5 days
- Product code: EKX (Handpiece, Direct Drive, Ac-Powered)
- 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
Longest line of descent: 2 generations back to K954722 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981679: TCM 3000 and TCM Endo, Nouvag AG (1999) Summary page 4.

## Indications for use
To be used for dental drilling and other dental drive applications.

Source page: https://510kreport.com/device/K993188
Methodology: https://510kreport.com/methodology