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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 K896382
Device Name MODIFIED GLUMA BONDING SYSTEM
Applicant
Heraeus Kulzer, Inc.
4315 S Lafayette Blvd.
South Bend,  IN  46614
Applicant Contact V ZIMMERMAN
Correspondent
Heraeus Kulzer, Inc.
4315 S Lafayette Blvd.
South Bend,  IN  46614
Correspondent Contact V ZIMMERMAN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received11/06/1989
Decision Date 02/01/1990
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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