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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K013400
Device Name SYNERGY FLOW
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 Number872.3690
Classification Product Code
EBF  
Date Received10/15/2001
Decision Date 12/10/2001
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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