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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name implant, endosseous, orthodontic
510(k) Number K120861
Device Name FIN-S MICROIMPLANT
Original Applicant
CREEKSIDE ORTHODONTICS
136 e. mallard dr.
boise,  ID  83706
Original Contact john t kalange
Regulation Number872.3640
Classification Product Code
OAT  
Date Received03/22/2012
Decision Date 02/21/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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