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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K994435
Device Name OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS
Applicant
JENERIC/PENTRON, INC.
53 NORTH PLAINS INDUSTRIAL RD.
P.O. BOX 724
WALLINGFORD,  CT  06492 -0724
Applicant Contact ANNMARIE TENERO
Correspondent
JENERIC/PENTRON, INC.
53 NORTH PLAINS INDUSTRIAL RD.
P.O. BOX 724
WALLINGFORD,  CT  06492 -0724
Correspondent Contact ANNMARIE TENERO
Regulation Number872.6660
Classification Product Code
EIH  
Date Received12/30/1999
Decision Date 02/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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