510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Calcitek, Inc.

Walker, MI, US

Calcitek, Inc. appears in FDA device records in Walker, MI. FDA records list 21 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
21
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 21 510(k) clearances for Calcitek, Inc. between 1984 and 1997. The busiest year on record is 1995, with 6. The most recent is 1997, with 1.

Clearances by year, as a table
510(k) clearance decisions for Calcitek, Inc., by decision year
YearClearances
19841
19851
19902
19911
19921
19932
19942
19956
19964
19971
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K962576SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K962106SPLINE DENTAL IMPLANT SYSTEMSDZESubstantially Equivalent
K9556195.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMSDZESubstantially Equivalent
K960021CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMSDZESubstantially Equivalent
K943604INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K946345INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K946319INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K946311INTEGRAL VII 3.25MM BIOINTEGRATED DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K943180INTEGRAL IV BIOINTEGRATED DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K944327INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K941608INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RINGDZESubstantially Equivalent
K925490INTEGRAL III BIOINTEGRATED DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K931440CALCITEK TORQUE WRENCH SYSTEMDZESubstantially Equivalent
K932274INTEGRAL III DENTAL IMPLANT ABUTMENTDZESubstantially Equivalent
K923562INTERGRAL III DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K915597BUR,DENTAL (76EJL)DZESubstantially Equivalent
K900694CASTABLE ABUTMENTSDZESubstantially Equivalent
K900549INTEGRAL PLUS BIOINTEGRATED DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K900545O-RING PROSTHETIC ATTACHMENT DEVICEDZESubstantially Equivalent
K852682CALCITITE BONE GRAFT MAT/ORAL & MAXILLOFACIAL SURGLYCSubstantially Equivalent
K840750HYDROXYLAPATITE COATED ENDOSSEOUS DENTDZESubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain