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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K020050
Device Name ENAMEL BONDING SYSTEM
Applicant
RITE-DENT MANUFACTURING CORP.
1056 EAST 33RD ST.
HIALEAH,  FL  33013 -3526
Applicant Contact CESAR E VELIZ
Correspondent
RITE-DENT MANUFACTURING CORP.
1056 EAST 33RD ST.
HIALEAH,  FL  33013 -3526
Correspondent Contact CESAR E VELIZ
Regulation Number872.3200
Classification Product Code
KLE  
Date Received01/07/2002
Decision Date 02/14/2002
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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