QUANTUM DENTAL IMPLANT SYSTEM

Implant, Endosseous, Root-form

QUANTUM BIOENGINEERING, LTD.

The following data is part of a premarket notification filed by Quantum Bioengineering, Ltd. with the FDA for Quantum Dental Implant System.

Pre-market Notification Details

Device IDK130787
510k NumberK130787
Device Name:QUANTUM DENTAL IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant QUANTUM BIOENGINEERING, LTD. 12264 El Camino Real, Suite 400 San Diego,  CA  92130
ContactLinda Schulz
CorrespondentLinda Schulz
QUANTUM BIOENGINEERING, LTD. 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 Received2013-03-21
Decision Date2013-06-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D825200130014HA0 K130787 000
D825200130011HA0 K130787 000
D825200130009HA0 K130787 000
D825200130008HA0 K130787 000

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