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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 K122069
Device Name STORM MINI SCREW
Applicant
LANCER ORTHODONTICS, INC.
2330 cousteau court
vista,  CA  92081
Contact larry walker
Regulation Number872.3640
Classification Product Code
OAT  
Date Received07/16/2012
Decision Date 04/11/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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