SCREWINDIRECT DENTAL IMPLANTS

Implant, Endosseous, Root-form

IMPLANT DIRECT LLC

The following data is part of a premarket notification filed by Implant Direct Llc with the FDA for Screwindirect Dental Implants.

Pre-market Notification Details

Device IDK080633
510k NumberK080633
Device Name:SCREWINDIRECT DENTAL IMPLANTS
ClassificationImplant, Endosseous, Root-form
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 CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-05
Decision Date2008-07-15
Summary:summary

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