Medical Device Manufacturer · US , Walker , MI

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

21 submissions · 21 cleared · Since 1984
21
Total
21
Cleared
0
Denied

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

21 devices
1-21 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
Cleared Jan 26, 1994
CALCITEK TORQUE WRENCH SYSTEM
K931440 · DZE
Dental · 310d
Cleared Nov 05, 1993
INTERGRAL III DENTAL IMPLANT SYSTEM
K923562 · DZE
Dental · 476d
Cleared Nov 05, 1993
INTEGRAL III DENTAL IMPLANT ABUTMENT
K932274 · DZE
Dental · 177d
Cleared Feb 05, 1992
BUR,DENTAL (76EJL)
K915597 · DZE
Dental · 54d
Cleared Feb 11, 1991
CASTABLE ABUTMENTS
K900694 · DZE
Dental · 363d
Cleared Jun 28, 1990
INTEGRAL PLUS BIOINTEGRATED DENTAL IMPLANT SYSTEM
K900549 · DZE
Dental · 143d
Cleared Jun 22, 1990
O-RING PROSTHETIC ATTACHMENT DEVICE
K900545 · DZE
Dental · 137d
Cleared Sep 23, 1985
CALCITITE BONE GRAFT MAT/ORAL & MAXILLOFACIAL SURG
K852682 · LYC
Dental · 90d
Cleared Apr 13, 1984
HYDROXYLAPATITE COATED ENDOSSEOUS DENT
K840750 · DZE
Dental · 50d
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