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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powder, porcelain
510(k) Number K992161
Device Name CERANA
Applicant
NORDISKA DENTAL AB
1205 DE LA VINA
SANTA BARBARA,  CA  93101
Applicant Contact CHRISTINE EMANUEL
Correspondent
NORDISKA DENTAL AB
1205 DE LA VINA
SANTA BARBARA,  CA  93101
Correspondent Contact CHRISTINE EMANUEL
Regulation Number872.6660
Classification Product Code
EIH  
Date Received06/25/1999
Decision Date 09/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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