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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
LAPORTE,  IN  46350 -0073
Applicant Contact NANCY S IATAROLA
Correspondent
TP ORTHODONTICS, INC.
100 CENTER PLAZA
LAPORTE,  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
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