# K230895: CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,

- Pathway: 510(k) (Traditional)
- Applicant: Cefla S.C.
- Decided: Apr 1, 2024 after 367 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: 7 generations back to K983183 (1998). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213022: CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED, Cefla S.C. (2022) Summary page 7.

## Indications for use
The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units. They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed. They are intended for professional use in dental surgery such as: preventive dentistry, restorative applications, endodontic treatment, prosthetic applications and implantology practices.

Source page: https://510kreport.com/device/K230895
Methodology: https://510kreport.com/methodology