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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 K874458
Device Name PRIME PLUS-POLYACRYLIC ACID BOND CONDITIONER
Applicant
Lustgarten Multi-Tech International, Inc.
1661 Worcester Rd., Suite 201
Framingham,  MA  01701
Applicant Contact J LUSTGARTEN
Correspondent
Lustgarten Multi-Tech International, Inc.
1661 Worcester Rd., Suite 201
Framingham,  MA  01701
Correspondent Contact J LUSTGARTEN
Regulation Number872.3275
Classification Product Code
EMA  
Date Received10/29/1987
Decision Date 03/18/1988
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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