INTEGRAL IV BIOINTEGRATED DENTAL IMPLANT SYSTEM

Implant, Endosseous, Root-form

CALCITEK, INC.

The following data is part of a premarket notification filed by Calcitek, Inc. with the FDA for Integral Iv Biointegrated Dental Implant System.

Pre-market Notification Details

Device IDK943180
510k NumberK943180
Device Name:INTEGRAL IV BIOINTEGRATED DENTAL IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant CALCITEK, INC. 2320 FARADAY AVE. Carlsbad,  CA  92008 -7216
ContactCarol A White
CorrespondentCarol A White
CALCITEK, INC. 2320 FARADAY AVE. Carlsbad,  CA  92008 -7216
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-01
Decision Date1995-09-21

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