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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Ceramic, Orthodontic
510(k) Number K950992
Device Name CERAMAFLEX BRACKET SYSTEM
Applicant
Tp Orthodontics, Inc.
100 Center Plaza
La Porte,  IN  46350 -0073
Applicant Contact NANCY S IATAROLA
Correspondent
Tp Orthodontics, Inc.
100 Center Plaza
La Porte,  IN  46350 -0073
Correspondent Contact NANCY S IATAROLA
Regulation Number872.5470
Classification Product Code
NJM  
Date Received03/03/1995
Decision Date 05/03/1995
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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