SPECTRA-SYSTEM ABUTMENTS 2008

Abutment, Implant, Dental, Endosseous

IMPLANT DIRECT LLC

The following data is part of a premarket notification filed by Implant Direct Llc with the FDA for Spectra-system Abutments 2008.

Pre-market Notification Details

Device IDK081101
510k NumberK081101
Device Name:SPECTRA-SYSTEM ABUTMENTS 2008
ClassificationAbutment, Implant, Dental, Endosseous
Applicant IMPLANT DIRECT LLC 27030 MALIBU HILLS RD. Calabasas Hills,  CA  91301
ContactThomas Gottenbos
CorrespondentThomas Gottenbos
IMPLANT DIRECT LLC 27030 MALIBU HILLS RD. Calabasas Hills,  CA  91301
Product CodeNHA  
CFR Regulation Number872.3630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-17
Decision Date2009-01-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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