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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 K962812
Device Name GLUMA DESENSITIZER/GLUMA 3 PRIMER
Applicant
HERAEUS KULZER, INC.
4315 SOUTH LAFAYETTE BLVD.
SOUTH BEND,  IN  46614 -2517
Applicant Contact CHERLY V ZIMMERMAN
Correspondent
HERAEUS KULZER, INC.
4315 SOUTH LAFAYETTE BLVD.
SOUTH BEND,  IN  46614 -2517
Correspondent Contact CHERLY V ZIMMERMAN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received07/18/1996
Decision Date 10/07/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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