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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 K121117
Device Name NDX ABUTMENTS
Applicant
NATIONAL DENTEX CORP
11234 el camino real
suite 200
san diego,  CA  92130
Applicant Contact linda k schulz
Correspondent
NATIONAL DENTEX CORP
11234 el camino real
suite 200
san diego,  CA  92130
Correspodent Contact linda k schulz
Regulation Number872.3630
Classification Product Code
NHA  
Date Received04/12/2012
Decision Date 12/14/2012
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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