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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name File, Pulp Canal, Endodontic
510(k) Number K812260
Device Name DYNA TRAK ENDODONTIC PREP. INSTRUMENT
Applicant
Inventive Technology Int'L., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Inventive Technology Int'L., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.4565
Classification Product Code
EKS  
Date Received08/12/1981
Decision Date 08/25/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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