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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 K160786
Device Name RODO Abutment System
Applicant
Rodo Medical, Inc.
690 Saratoga Ave. Suite 100
San Jose,  CA  95129
Applicant Contact Michael Parsons
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 Received03/22/2016
Decision Date 11/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Clinical Trials NCT02388425
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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