Cleared Traditional

K260356 - EndoColibri

K260356 is an FDA 510(k) clearance for EndoColibri, manufactured by Koehrer Medical Engineering GmbH. The device is a Class 1 Dental device with product code NYL cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K260356 · Koehrer Medical Engineering GmbH · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
268d
Days
Class 1
Risk

K260356 is an FDA 510(k) clearance for the EndoColibri. Classified as Handpiece, Air-powered, Root Canal Irrigation (product code NYL), Class I - General Controls.

Submitted by Koehrer Medical Engineering GmbH (Neuss, DE). The FDA issued a Cleared decision on October 29, 2026 after a review of 268 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K260356

510(k) Number K260356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2026
Decision Date October 29, 2026
Days to Decision 268 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 128d · This submission: 268d
Pathway characteristics
Predicate-based equivalence.

NYL Device Classification - Class 1, General Controls

Product Code NYL Handpiece, Air-powered, Root Canal Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
Definition To Clean The Root Canal Prior To Filling And Used For Root Canal Irrigation.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - NYL Handpiece, Air-powered, Root Canal Irrigation

Devices cleared under the same product code (NYL) and FDA review panel - the closest regulatory comparables to K260356.
PS System
K211721 · Inter-Med, Inc. · Dec 2021
EndoVac Pure
K162436 · Kerr Corporation · Dec 2016
ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM
K140685 · Sybron Endo · Jul 2014
VATEA ENDONTIC IRRIGATION SYSTEM
K100606 · Redent-Nova , Ltd. · May 2010
RINSENDO
K052271 · Air Techniques, Inc. · May 2006
K260356 · EndoColibri
Download PDF FDA Summary Koehrer Medical Engin…