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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 K901621
Device Name NEW PER-FIT(R) IMPROVED
Applicant
Dental Product Co.
Box 42
Hammett,  ID  83627
Applicant Contact VAN HANDEL
Correspondent
Dental Product Co.
Box 42
Hammett,  ID  83627
Correspondent Contact VAN HANDEL
Regulation Number872.3760
Classification Product Code
EBI  
Date Received04/05/1990
Decision Date 06/26/1990
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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