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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K994359
Device Name BOND 1 C & B
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 Number872.3200
Classification Product Code
KLE  
Date Received12/27/1999
Decision Date 03/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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