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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gutta-Percha
510(k) Number K042870
Device Name ENDO TWINN
Applicant
Endo Twinn B.V.
Danzigerkade 17
Amsterdam,  NL 1013 AP
Applicant Contact F.M. VERHOEVEN
Correspondent
Kema Quality B.V.
4377 County Line Rd.
Chalfont,  PA  18914
Correspondent Contact J.A. VAN VUGT
Regulation Number872.3850
Classification Product Code
EKM  
Date Received10/18/2004
Decision Date 01/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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