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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dental cement w/out zinc-oxide eugenol as an ulcer covering for pain relief
510(k) Number K073209
Device Name MAXCEM 2
Applicant
KERR CORPORATION
1717 WEST COLLINS AVE.
ORANGE,  CA  92867
Applicant Contact COLLEEN BOSWELL
Correspondent
KERR CORPORATION
1717 WEST COLLINS AVE.
ORANGE,  CA  92867
Correspondent Contact COLLEEN BOSWELL
Regulation Number872.3275
Classification Product Code
MZW  
Subsequent Product Code
EMA  
Date Received11/14/2007
Decision Date 01/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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