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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K032195
Device Name DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT
Applicant
Dentaurum
10 Pheasant Run
Newtown,  PA  18940
Applicant Contact JAN A DOORSCHODT
Correspondent
Dentaurum
10 Pheasant Run
Newtown,  PA  18940
Correspondent Contact JAN A DOORSCHODT
Regulation Number872.3750
Classification Product Code
DYH  
Date Received07/18/2003
Decision Date 10/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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