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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 K970246
Device Name EDTA CAVIT
Applicant
Karolinski
Kungstensgatan 56nb
S-113 29
Stockholm,  SE
Applicant Contact SVEN LINDSKOG
Correspondent
Karolinski
Kungstensgatan 56nb
S-113 29
Stockholm,  SE
Correspondent Contact SVEN LINDSKOG
Regulation Number872.3690
Classification Product Code
EBF  
Date Received01/21/1997
Decision Date 04/16/1997
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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