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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K150295
Device Name LOCATOR RTx
Applicant
ZEST ANCHORS, INC.
2061 WINERIDGE PL.
escondido,  CA  92029
Applicant Contact annie wrigth
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
san diego,  CA  92130
Correspondent Contact linda k schulz
Regulation Number872.3630
Classification Product Code
NHA  
Date Received02/06/2015
Decision Date 07/24/2015
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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