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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
Applicant
Creekside Orthodontics
136 E. Mallard Dr.
Boise,  ID  83706
Applicant Contact JOHN T KALANGE
Correspondent
Creekside Orthodontics
136 E. Mallard Dr.
Boise,  ID  83706
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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