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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 K061266
Device Name ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR
Applicant
ORTHO ORGANIZERS, INC.
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO,  CA  92130
Applicant Contact FLOYD G LARSON
Correspondent
ORTHO ORGANIZERS, INC.
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO,  CA  92130
Correspondent Contact FLOYD G LARSON
Regulation Number872.3640
Classification Product Code
OAT  
Date Received05/05/2006
Decision Date 07/31/2006
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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