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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 K933360
Device Name GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER
Applicant
Miles Inc., Dental Products
4315 S Lafayette Blvd.
South Bend,  IN  46614
Applicant Contact CHERYL V ZIMMERMAN
Correspondent
Miles Inc., Dental Products
4315 S Lafayette Blvd.
South Bend,  IN  46614
Correspondent Contact CHERYL V ZIMMERMAN
Regulation Number872.3200
Classification Product Code
KLE  
Date Received07/09/1993
Decision Date 11/22/1994
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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