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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Gold-Based Noble Metal
510(k) Number K001051
Device Name RX EVEREST
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 Number872.3060
Classification Product Code
EJT  
Date Received04/03/2000
Decision Date 04/28/2000
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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