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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 K940737
Device Name EDTA GEL (TM)
Applicant
Karolinska Institutet
9229 Cranford Dr.
Potomac,  MD  20854
Applicant Contact SVEN LINDSKOG
Correspondent
Karolinska Institutet
9229 Cranford Dr.
Potomac,  MD  20854
Correspondent Contact SVEN LINDSKOG
Regulation Number872.3690
Classification Product Code
EBF  
Date Received02/17/1994
Decision Date 06/03/1994
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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