Legacy SMARTBase Abutments

Abutment, Implant, Dental, Endosseous

Implant Direct Sybron Manufacturing LLC

The following data is part of a premarket notification filed by Implant Direct Sybron Manufacturing Llc with the FDA for Legacy Smartbase Abutments.

Pre-market Notification Details

Device IDK191458
510k NumberK191458
Device Name:Legacy SMARTBase Abutments
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks,  CA  91362
ContactReina Choi
CorrespondentYarmela Pavlovic
Hogan Lovells U.S. LLP 3 Embarcadero Center #1500 San Francisco,  CA  94111
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-31
Decision Date2019-10-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10841307122807 K191458 000
10841307129967 K191458 000
10841307129974 K191458 000
10841307127383 K191458 000
10841307127390 K191458 000
10841307127406 K191458 000
10841307122975 K191458 000
10841307122982 K191458 000
10841307122999 K191458 000
10841307122715 K191458 000
10841307122722 K191458 000
10841307122739 K191458 000
10841307122746 K191458 000
10841307122753 K191458 000
10841307122760 K191458 000
10841307122777 K191458 000
10841307122784 K191458 000
10841307122791 K191458 000
10841307129950 K191458 000

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