OSSEOSPEED PROFILE EV

Implant, Endosseous, Root-form

DENTSPLY IMPLANTS MANUFACTURING GMBH

The following data is part of a premarket notification filed by Dentsply Implants Manufacturing Gmbh with the FDA for Osseospeed Profile Ev.

Pre-market Notification Details

Device IDK130999
510k NumberK130999
Device Name:OSSEOSPEED PROFILE EV
ClassificationImplant, Endosseous, Root-form
Applicant DENTSPLY IMPLANTS MANUFACTURING GMBH 12264 El Camino Real, Suite 400 San Diego,  CA  92130
ContactLinda K Schulz
CorrespondentLinda K Schulz
DENTSPLY IMPLANTS MANUFACTURING GMBH 12264 El Camino Real, Suite 400 San Diego,  CA  92130
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-10
Decision Date2013-10-25
Summary:summary

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