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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Metal, Orthodontic
510(k) Number K923440
Device Name APEX DIRECT BONDED BRACKETS
Applicant
Apex Orthodontics, Inc.
608 Bent Creek
Desoto,  TX  75115
Applicant Contact OSCAR LINNSTAEDTER
Correspondent
Apex Orthodontics, Inc.
608 Bent Creek
Desoto,  TX  75115
Correspondent Contact OSCAR LINNSTAEDTER
Regulation Number872.5410
Classification Product Code
EJF  
Date Received07/13/1992
Decision Date 03/31/1993
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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