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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 K933831
Device Name PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC.
Applicant
Nu-Dent, Inc.
352 Seventh Ave.
Suite 1218
New York,  NY  10001
Applicant Contact PETER H JEFFER
Correspondent
Nu-Dent, Inc.
352 Seventh Ave.
Suite 1218
New York,  NY  10001
Correspondent Contact PETER H JEFFER
Regulation Number872.3760
Classification Product Code
EBI  
Date Received08/05/1993
Decision Date 12/06/1993
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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