# K213897: Pro M Class

- Pathway: 510(k) (Traditional)
- Applicant: Saeyang Microtech Co., Ltd.
- Decided: Sep 19, 2022 after 279 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: 4 generations back to K971350 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111616: E-CUBE, Saeshin Precision Co., Ltd. (2011) Summary page 4.

## Indications for use
The PRO M CLASS is used by dental professionals for orthodontic and endodontic procedures using a root canal instrument and tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthodontic treatment.

Source page: https://510kreport.com/device/K213897
Methodology: https://510kreport.com/methodology