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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Direct Drive, Ac-Powered
510(k) Number K232551
Device Name EM-07 Cordless Endo Motor
Applicant
Forum Engineering Technologies (96) , Ltd.
40 Hutsot Hayotser St.
Ashkelon,  IL 7878563
Applicant Contact Nissim Oz
Correspondent
DD Consulting
401-4080 Living Arts Dr.
Mississauga,  CA L5B4N3
Correspondent Contact Danijela Domljanovic
Regulation Number872.4200
Classification Product Code
EKX  
Subsequent Product Code
LQY  
Date Received08/23/2023
Decision Date 07/09/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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