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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 K990056
Device Name JELDENT MULTICRYL
Applicant
J.F. Jelenko & Co., Inc.
99 Business Park Dr.
Armonk,  NY  10504
Applicant Contact RAPHAEL JUDKINS
Correspondent
J.F. Jelenko & Co., Inc.
99 Business Park Dr.
Armonk,  NY  10504
Correspondent Contact RAPHAEL JUDKINS
Regulation Number872.3760
Classification Product Code
EBI  
Date Received01/07/1999
Decision Date 03/25/1999
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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