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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Metal, Base
510(k) Number K003037
Device Name JEWEL CAST III
Applicant
Jeneric/Pentron, Inc.
53 N. Plains Industrial Rd.
P.O. Box 724
Wallingford,  CT  06492 -0724
Applicant Contact ANNMARIE TENERO
Correspondent
Jeneric/Pentron, Inc.
53 N. Plains Industrial Rd.
P.O. Box 724
Wallingford,  CT  06492 -0724
Correspondent Contact ANNMARIE TENERO
Regulation Number872.3710
Classification Product Code
EJH  
Date Received09/29/2000
Decision Date 12/05/2000
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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