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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bur, Dental
510(k) Number K080687
Device Name SMARTBURS
Applicant
S.S. White Burs, Inc.
1145 Towbin Ave.
Lakewood,  NJ  08701
Applicant Contact DEREK GLADDEN
Correspondent
S.S. White Burs, Inc.
1145 Towbin Ave.
Lakewood,  NJ  08701
Correspondent Contact DEREK GLADDEN
Regulation Number872.3240
Classification Product Code
EJL  
Date Received03/11/2008
Decision Date 06/20/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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