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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 K852660
Device Name ETCH AND BOND
Applicant
DENTSPLY INTL.
570 WEST COLLEGE AVE.
P.O. BOX 872
YORK,  PA  17405
Applicant Contact JOHN O SEMMELMAN
Correspondent
DENTSPLY INTL.
570 WEST COLLEGE AVE.
P.O. BOX 872
YORK,  PA  17405
Correspondent Contact JOHN O SEMMELMAN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received06/24/1985
Decision Date 07/25/1985
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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