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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Root Canal Irrigation
510(k) Number K260356
Device Name EndoColibri
Applicant
Koehrer Medical Engineering GmbH
Adolf-Flecken-Str. 10
North Rhine-Westphalia
Neuss,  DE 41460
Applicant Contact Colleen Boswell
Correspondent
Koehrer Medical Engineering GmbH
Adolf-Flecken-Str. 10
North Rhine-Westphalia
Neuss,  DE 41460
Correspondent Contact Colleen Boswell
Regulation Number872.4200
Classification Product Code
NYL  
Date Received02/03/2026
Decision Date 10/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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