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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K051866
Device Name PREMIER TEMPORARY CEMENT
Applicant
Premier Dental Products Co.
1710 Romano Dr.
Plymouth Meeting,  PA  19462
Applicant Contact VINCE D'ALESSANDRO
Correspondent
Premier Dental Products Co.
1710 Romano Dr.
Plymouth Meeting,  PA  19462
Correspondent Contact VINCE D'ALESSANDRO
Regulation Number872.3275
Classification Product Code
EMA  
Date Received07/11/2005
Decision Date 09/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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