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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 K952643
Device Name RIGHT-ON ADHESIVE BOUDING SYSTEM
Applicant
Tp Orthodontics, Inc.
100 Center Plz.
La Porte,  IN  46350
Applicant Contact NANCY S IATAROLA
Correspondent
Tp Orthodontics, Inc.
100 Center Plz.
La Porte,  IN  46350
Correspondent Contact NANCY S IATAROLA
Regulation Number872.3750
Classification Product Code
DYH  
Date Received06/09/1995
Decision Date 07/11/1995
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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