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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 K991996
Device Name IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR
Applicant
Denplus, Inc.
4235 Beaconsfield
Montreal, Quebec,  CA H4A 2H4
Applicant Contact SHUOJIA DONG
Correspondent
Denplus, Inc.
4235 Beaconsfield
Montreal, Quebec,  CA H4A 2H4
Correspondent Contact SHUOJIA DONG
Regulation Number872.3760
Classification Product Code
EBI  
Date Received06/14/1999
Decision Date 09/08/1999
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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