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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Polishing, Abrasive, Oral Cavity
510(k) Number K903986
Device Name SWIRL PROPHYLAXIS PASTE
Applicant
Bio-Medica Concepts
8645 Cincinnati-Columbus Rd.,
Unit B
West Chester,  OH  45069
Applicant Contact KOSTI, DDS
Correspondent
Bio-Medica Concepts
8645 Cincinnati-Columbus Rd.,
Unit B
West Chester,  OH  45069
Correspondent Contact KOSTI, DDS
Regulation Number872.6030
Classification Product Code
EJR  
Date Received08/29/1990
Decision Date 03/28/1991
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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