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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 K931812
Device Name NEW DENTINE ADHESIVE
Applicant
DENTSPLY INTL.
570 WEST COLLEGE AVE.
P.O. BOX 872
YORK,  PA  17405
Applicant Contact JEFFERY LEHN
Correspondent
DENTSPLY INTL.
570 WEST COLLEGE AVE.
P.O. BOX 872
YORK,  PA  17405
Correspondent Contact JEFFERY LEHN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received04/12/1993
Decision Date 07/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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