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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 K941899
Device Name SDI COMPOSTIES
Applicant
Southern Dental Industries, Inc.
7020 Koll Center Pkwy.
Suite 140
Pleasanton,  CA  94566
Applicant Contact JUDY HAGENBAUGH
Correspondent
Southern Dental Industries, Inc.
7020 Koll Center Pkwy.
Suite 140
Pleasanton,  CA  94566
Correspondent Contact JUDY HAGENBAUGH
Regulation Number872.3690
Classification Product Code
EBF  
Date Received04/19/1994
Decision Date 07/05/1994
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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