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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K020178
Device Name BELLEGLASS HP MODELING GEL
Applicant
Kerr Dental Materials Center
1717 W. Collins Ave.
Orange,  CA  92867
Applicant Contact COLLEEN BOSWELL
Correspondent
Kerr Dental Materials Center
1717 W. Collins Ave.
Orange,  CA  92867
Correspondent Contact COLLEEN BOSWELL
Regulation Number872.3770
Classification Product Code
EBG  
Date Received01/18/2002
Decision Date 03/15/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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