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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 K000213
Device Name JELDENT BASIC LINE
Applicant
J.F. Jelenko & Co.
99 Business Park Dr.
Armonk,  NY  10504
Applicant Contact RAPHAEL JUDKINS
Correspondent
J.F. Jelenko & Co.
99 Business Park Dr.
Armonk,  NY  10504
Correspondent Contact RAPHAEL JUDKINS
Regulation Number872.3590
Classification Product Code
ELM  
Date Received01/24/2000
Decision Date 04/06/2000
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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