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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K001414
Device Name KWIKKMODEL
Applicant
R-DENTAL DENTALERZEUGNISSE GMBH
WINTERHUDER WEG 88
HAMBURG,  DE D-22085
Applicant Contact ANDREAS SPRAFKE
Correspondent
R-DENTAL DENTALERZEUGNISSE GMBH
WINTERHUDER WEG 88
HAMBURG,  DE D-22085
Correspondent Contact ANDREAS SPRAFKE
Regulation Number872.3660
Classification Product Code
ELW  
Date Received05/04/2000
Decision Date 08/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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