Rodo Abutment System

Abutment, Implant, Dental, Endosseous

RODO Medical, Inc.

The following data is part of a premarket notification filed by Rodo Medical, Inc. with the FDA for Rodo Abutment System.

Pre-market Notification Details

Device IDK193274
510k NumberK193274
Device Name:Rodo Abutment System
ClassificationAbutment, Implant, Dental, Endosseous
Applicant RODO Medical, Inc. 6399 San Ignacio Ave., Suite 100 San Jose,  CA  95119
ContactJames Park
CorrespondentRandy Prebula
Hogan Lovells US LLP 555 13th St. NW Washington,  DC  20004
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-26
Decision Date2020-02-27

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