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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 K072604
Device Name DUO TEMP
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 Received09/17/2007
Decision Date 11/16/2007
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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