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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K072479
Device Name FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD
Applicant
Rapid Injection Systems Corp.
30 Northport Rd.
Sound Beach,  NY  11789
Applicant Contact SOL SOROCA
Correspondent
Rapid Injection Systems Corp.
30 Northport Rd.
Sound Beach,  NY  11789
Correspondent Contact SOL SOROCA
Regulation Number872.3760
Classification Product Code
EBI  
Subsequent Product Code
MQC  
Date Received09/04/2007
Decision Date 11/09/2007
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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