InterActive 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 Interactive Smartbase Abutments.

Pre-market Notification Details

Device IDK181359
510k NumberK181359
Device Name:InterActive SMARTBase Abutments
ClassificationAbutment, Implant, Dental, Endosseous
Applicant Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks,  CA  91362
ContactReina Choi
CorrespondentReina Choi
Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks,  CA  91362
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-22
Decision Date2018-08-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10841307129134 K181359 000
10841307129127 K181359 000
10841307133896 K181359 000

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