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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K031752
Device Name COLTOSOL F
Applicant
Coltene/Whaledent, Inc.
235 Ascot Pkwy.
Cuyahoga Falls,  OH  44223
Applicant Contact H.J. VOGELSTEIN
Correspondent
Coltene/Whaledent, Inc.
235 Ascot Pkwy.
Cuyahoga Falls,  OH  44223
Correspondent Contact H.J. VOGELSTEIN
Regulation Number872.3275
Classification Product Code
EMA  
Date Received06/05/2003
Decision Date 08/05/2003
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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