INTEGRAL PLUS 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 Plus Biointegrated Dental Implant System.

Pre-market Notification Details

Device IDK900549
510k NumberK900549
Device Name:INTEGRAL PLUS BIOINTEGRATED DENTAL IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant CALCITEK, INC. 2320 FARADAY AVE. Carlsbad,  CA  92008 -7216
ContactM Carlson
CorrespondentM Carlson
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 Received1990-02-05
Decision Date1990-06-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889024011380 K900549 000
00889024010857 K900549 000
00889024010864 K900549 000
00889024010871 K900549 000
00889024010901 K900549 000
00889024010918 K900549 000
00889024011045 K900549 000
00889024011052 K900549 000
00889024011069 K900549 000
00889024011076 K900549 000
00889024011137 K900549 000
00889024011168 K900549 000
00889024011175 K900549 000
00889024011182 K900549 000
00889024011199 K900549 000
00889024011243 K900549 000
00889024011250 K900549 000
00889024011267 K900549 000
00889024011236 K900549 000

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