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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Point, Paper, Endodontic
510(k) Number K843017
Device Name ABSORBENT ENDODONTIC POINT
Applicant
United Dental Mfg., Inc.
2823 N. Australian Ave.
West Palm Beach,  FL  33407
Applicant Contact EDWARD ZDARSKY
Correspondent
United Dental Mfg., Inc.
2823 N. Australian Ave.
West Palm Beach,  FL  33407
Correspondent Contact EDWARD ZDARSKY
Regulation Number872.3830
Classification Product Code
EKN  
Date Received07/31/1984
Decision Date 01/09/1985
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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