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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Denture, Plastic, Teeth
510(k) Number K940244
Device Name VERIDENT PLUS, OPTIFORM
Applicant
Lactona Corp.
201 Commerce Dr.
P.O. Box 1007
Montgomeryville,  PA  18936 -1007
Applicant Contact ALBERT CESPUGLIO
Correspondent
Lactona Corp.
201 Commerce Dr.
P.O. Box 1007
Montgomeryville,  PA  18936 -1007
Correspondent Contact ALBERT CESPUGLIO
Regulation Number872.3590
Classification Product Code
ELM  
Date Received01/19/1994
Decision Date 05/02/1994
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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