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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 K112707
Model 180-12-1XXX-180-12-6XXX
Device Name GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM
Applicant
ORTHO TECHNOLOGY, INC
17401 commerce park blvd.
tampa,  FL  33647
Contact jodi hutchins
Regulation Number872.5470
Classification Product Code
NJM  
Date Received09/19/2011
Decision Date 01/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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