Custom Legacy And Custom InterActive Titanium 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 Custom Legacy And Custom Interactive Titanium Abutments.

Pre-market Notification Details

Device IDK192218
510k NumberK192218
Device Name:Custom Legacy And Custom InterActive Titanium Abutments
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Implant Direct Sybron Manufacturing , LLC 3050 East Hillcrest Drive Thousand Oaks,  CA  91362
ContactReina Choi
CorrespondentKelliann Payne
Hogan Lovells LLP 1735 Market Street 23rd Floor Philadelphia,  PA  19103
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-15
Decision Date2020-05-08

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