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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name varnish, cavity
510(k) Number K093575
Device Name GLUMA DESENSITIZER POWER GEL
Applicant
HERAEUS KULZER, LLC
300 HERAEUS WAY
SOUTH BEND,  IN  46614
Applicant Contact CHERYL V ZIMMERMAN
Correspondent
HERAEUS KULZER, LLC
300 HERAEUS WAY
SOUTH BEND,  IN  46614
Correspondent Contact CHERYL V ZIMMERMAN
Regulation Number872.3260
Classification Product Code
LBH  
Date Received11/18/2009
Decision Date 03/05/2010
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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