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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 K974390
Device Name GLUMA ONE BOND
Applicant
Heraeus Kulzer, Inc.
4315 S. Lafayette Blvd.
South Bend,  IN  46614 -2517
Applicant Contact CHERYL V ZIMMERMAN
Correspondent
Heraeus Kulzer, Inc.
4315 S. Lafayette Blvd.
South Bend,  IN  46614 -2517
Correspondent Contact CHERYL V ZIMMERMAN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received11/21/1997
Decision Date 02/04/1998
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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