UNIPLANT DENTAL IMPLANT SYSTEM

Implant, Endosseous, Root-form

UNIVERSAL IMPLANT SYSTEMS, INC.

The following data is part of a premarket notification filed by Universal Implant Systems, Inc. with the FDA for Uniplant Dental Implant System.

Pre-market Notification Details

Device IDK011574
510k NumberK011574
Device Name:UNIPLANT DENTAL IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant UNIVERSAL IMPLANT SYSTEMS, INC. 4329 GRAYDON RD. San Diego,  CA  92130
ContactFloyd G Larson
CorrespondentFloyd G Larson
UNIVERSAL IMPLANT SYSTEMS, INC. 4329 GRAYDON RD. San Diego,  CA  92130
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-22
Decision Date2001-09-28
Summary:summary

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