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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 K891536
Device Name ENAMEL MICROABRASION COMPOUND
Applicant
Premier Dental Products Co.
1710 Romano Dr.
P.O. Box 111
Norristown,  PA  19401
Applicant Contact WILLIAM J FREZEL
Correspondent
Premier Dental Products Co.
1710 Romano Dr.
P.O. Box 111
Norristown,  PA  19401
Correspondent Contact WILLIAM J FREZEL
Regulation Number872.6030
Classification Product Code
EJR  
Date Received03/17/1989
Decision Date 06/09/1989
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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