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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, root-form
510(k) Number K133991
Device Name ISY
Applicant
ALTATEC GMBH
12264 EL CAMINO REAL
SUITE 400
san diego,  CA  92130
Applicant Contact linda schulz
Correspondent
ALTATEC GMBH
12264 EL CAMINO REAL
SUITE 400
san diego,  CA  92130
Correspondent Contact linda schulz
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received12/26/2013
Decision Date 08/06/2014
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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