# K231864: Fiber Optic Brushless Electronic Micromotor, model: iM100

- Pathway: 510(k) (Traditional)
- Applicant: Codent Technical Industry Co., Ltd.
- Decided: Mar 11, 2024 after 259 days
- Product code: EBW (Controller, Foot, Handpiece And Cord)
- 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: 6 generations back to K983183 (1998). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181858: Electric Handpiece Motor, W&H Dentalwerk Buermoos GmbH (2019) Summary page 5.

## Indications for use
The Fiber Optic Brushless Electric Micromotor Set (iM100) is a brushless DC electric micromotor controlled by a control unit. It is intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed. It is indicated for use in the field of preventive dentistry, restorative applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.

Source page: https://510kreport.com/device/K231864
Methodology: https://510kreport.com/methodology