510(k) clearance

EndoColibri

FDA 510(k) source

510(k) number

K260356

Applicant

Koehrer Medical Engineering GmbH

Decision date

Oct 29, 2026

Date received

Feb 3, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

NYL

Device type

Handpiece, Air-Powered, Root Canal Irrigation

Device class

Class I

Regulation

21 CFR 872.4200

Advisory committee

Dental

Statement or summary

Summary

Third party

N

Location

Neuss, DE