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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 K050426
Device Name TEMPOSIL, MODEL 6720
Applicant
Coltene/Whaledent AG
1349 Lexington Ave.
New York,  NY  10128
Applicant Contact HENRY J VOGELSTEIN
Correspondent
Coltene/Whaledent AG
1349 Lexington Ave.
New York,  NY  10128
Correspondent Contact HENRY J VOGELSTEIN
Regulation Number872.3275
Classification Product Code
EMA  
Date Received02/18/2005
Decision Date 03/18/2005
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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