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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 K903003
Device Name MPS DIAMOND POLISHING GEL
Applicant
Abrasive Technology, Inc.
8400 Green Meadows Dr.
P.O. Box 6127
Westerville,  OH  43081
Applicant Contact MARK E WATKINS
Correspondent
Abrasive Technology, Inc.
8400 Green Meadows Dr.
P.O. Box 6127
Westerville,  OH  43081
Correspondent Contact MARK E WATKINS
Regulation Number872.6030
Classification Product Code
EJR  
Date Received07/09/1990
Decision Date 08/29/1990
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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