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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 K922615
Device Name COLTENE A.R.T. BOND
Applicant
Coltene/Whaledent, Inc.
236 Firth Ave.
New York,  NY  10001
Applicant Contact VOGELSTEIN
Correspondent
Coltene/Whaledent, Inc.
236 Firth Ave.
New York,  NY  10001
Correspondent Contact VOGELSTEIN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received06/02/1992
Decision Date 08/03/1992
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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