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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Plastic, Orthodontic
510(k) Number K082207
Device Name ORTHOCAD IQ
Applicant
Cadent, Inc.
1700 Pennsylvania Ave., NW
Washington,  DC  20006
Applicant Contact LAURIE CLARKE
Correspondent
Cadent, Inc.
1700 Pennsylvania Ave., NW
Washington,  DC  20006
Correspondent Contact LAURIE CLARKE
Regulation Number872.5470
Classification Product Code
DYW  
Subsequent Product Codes
EJF   NJM  
Date Received08/05/2008
Decision Date 10/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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