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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Post, Root Canal
510(k) Number K934192
Device Name PARAPOST XT SYSTEM
Applicant
Coltene/Whaledent, Inc.
750 Corporate Dr.
Mahwah,  NJ  07430 -2009
Applicant Contact H.J. VOGELSTEIN
Correspondent
Coltene/Whaledent, Inc.
750 Corporate Dr.
Mahwah,  NJ  07430 -2009
Correspondent Contact H.J. VOGELSTEIN
Regulation Number872.3810
Classification Product Code
ELR  
Date Received08/26/1993
Decision Date 06/06/1994
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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