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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K992292
Device Name GLUMA COMFORT BOND + DESENSITIZER
Applicant
Heraeus Kulzer, Inc.
4315 S Lafayette Blvd.
South Bend,  IN  46614
Applicant Contact CHERYL V ZIMMERMAN
Correspondent
Heraeus Kulzer, Inc.
4315 S Lafayette Blvd.
South Bend,  IN  46614
Correspondent Contact CHERYL V ZIMMERMAN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received07/07/1999
Decision Date 10/01/1999
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
Recalls CDRH Recalls
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