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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 K950514
Device Name TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT
Applicant
3M Unitek
2724 S. Peck Rd.
Monrovia,  CA  91016
Applicant Contact MARLYN SCHEFF
Correspondent
3M Unitek
2724 S. Peck Rd.
Monrovia,  CA  91016
Correspondent Contact MARLYN SCHEFF
Regulation Number872.3750
Classification Product Code
DYH  
Date Received02/06/1995
Decision Date 03/07/1995
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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