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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 K010240
Device Name POLYCARBOXYLATE (PCA) CEMENT
Applicant
Rite-Dent Manufacturing Corp.
1056 E. 33rd St.
Hialeah,  FL  33013 -3526
Applicant Contact CESAR E VELIZ
Correspondent
Rite-Dent Manufacturing Corp.
1056 E. 33rd St.
Hialeah,  FL  33013 -3526
Correspondent Contact CESAR E VELIZ
Regulation Number872.3275
Classification Product Code
EMA  
Date Received01/25/2001
Decision Date 03/27/2001
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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