INTEGRAL VII 4.9MM 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 Vii 4.9mm Biointegrated Dental Implant System.

Pre-market Notification Details

Device IDK946319
510k NumberK946319
Device Name:INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant CALCITEK, INC. 2320 FARADAY AVE. Carlsbad,  CA  92008 -7216
ContactCarol White
CorrespondentCarol 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 Received1994-12-28
Decision Date1995-11-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.