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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 K033760
Device Name ONE COAT SE BOND
Applicant
Coltene/Whaledent, Inc.
1349 Lexington Ave.
New York,  NY  10128
Applicant Contact HENRY J VOGELSTEIN
Correspondent
Coltene/Whaledent, Inc.
1349 Lexington Ave.
New York,  NY  10128
Correspondent Contact HENRY J VOGELSTEIN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received12/02/2003
Decision Date 01/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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