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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sealant, Pit And Fissure, And Conditioner
510(k) Number K011822
Device Name PIT AND FISSURE CHEMICAL CURING SEALANT
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 Number872.3765
Classification Product Code
EBC  
Date Received06/11/2001
Decision Date 08/07/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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