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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 K993710
Device Name MODIFICATION OF PARAPOST CEMENT
Applicant
Coltene/Whaledent, Inc.
750 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact H.J. VOGELSTEIN
Correspondent
Coltene/Whaledent, Inc.
750 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact H.J. VOGELSTEIN
Regulation Number872.3275
Classification Product Code
EMA  
Date Received11/03/1999
Decision Date 12/21/1999
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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