Medical Device Manufacturer · US , Walker , MI

Calcitek, Inc. - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 1984

Recent clearances: SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM, SPLINE DENTAL IMPLANT SYSTEMS, 5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS

21
Total
21
Cleared
0
Denied

FDA 510(k) Regulatory Record - Calcitek, Inc. Dental ✕

21 devices
1-12 of 21
Cleared Feb 10, 1997
SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM
K962576 · DZE
Dental · 224d
Cleared Aug 29, 1996
SPLINE DENTAL IMPLANT SYSTEMS
K962106 · DZE
Dental · 90d
Cleared Mar 08, 1996
5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS
K955619 · DZE
Dental · 88d
Cleared Feb 08, 1996
INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM
K943604 · DZE
Dental · 563d
Cleared Feb 08, 1996
CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMS
K960021 · DZE
Dental · 37d
Cleared Nov 15, 1995
INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM
K946319 · DZE
Dental · 322d
Cleared Nov 15, 1995
INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEM
K946345 · DZE
Dental · 320d
Cleared Oct 04, 1995
INTEGRAL VII 3.25MM BIOINTEGRATED DENTAL IMPLANT SYSTEM
K946311 · DZE
Dental · 280d
Cleared Sep 21, 1995
INTEGRAL IV BIOINTEGRATED DENTAL IMPLANT SYSTEM
K943180 · DZE
Dental · 447d
Cleared May 16, 1995
INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM
K944327 · DZE
Dental · 256d
Cleared May 05, 1995
INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING
K941608 · DZE
Dental · 399d
Cleared Aug 01, 1994
INTEGRAL III BIOINTEGRATED DENTAL IMPLANT SYSTEM
K925490 · DZE
Dental · 637d
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