Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Calcitek, Inc. — Predicate Candidate Screening

21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

256 daysmedian FDA review time

476 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days
K962576	SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM	Calcitek, Inc.	1997-02-10	224
K962106	SPLINE DENTAL IMPLANT SYSTEMS	Calcitek, Inc.	1996-08-29	90
K955619	5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS	Calcitek, Inc.	1996-03-08	88
K943604	INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM	Calcitek, Inc.	1996-02-08	563
K960021	CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMS	Calcitek, Inc.	1996-02-08	37
K946345	INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEM	Calcitek, Inc.	1995-11-15	320
K946319	INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM	Calcitek, Inc.	1995-11-15	322
K946311	INTEGRAL VII 3.25MM BIOINTEGRATED DENTAL IMPLANT SYSTEM	Calcitek, Inc.	1995-10-04	280
K943180	INTEGRAL IV BIOINTEGRATED DENTAL IMPLANT SYSTEM	Calcitek, Inc.	1995-09-21	447
K944327	INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM	Calcitek, Inc.	1995-05-16	256
K941608	INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING	Calcitek, Inc.	1995-05-05	399
K925490	INTEGRAL III BIOINTEGRATED DENTAL IMPLANT SYSTEM	Calcitek, Inc.	1994-08-01	637
K931440	CALCITEK TORQUE WRENCH SYSTEM	Calcitek, Inc.	1994-01-26	310
K932274	INTEGRAL III DENTAL IMPLANT ABUTMENT	Calcitek, Inc.	1993-11-05	177
K923562	INTERGRAL III DENTAL IMPLANT SYSTEM	Calcitek, Inc.	1993-11-05	476
K915597	BUR,DENTAL (76EJL)	Calcitek, Inc.	1992-02-05	54
K900694	CASTABLE ABUTMENTS	Calcitek, Inc.	1991-02-11	363
K900549	INTEGRAL PLUS BIOINTEGRATED DENTAL IMPLANT SYSTEM	Calcitek, Inc.	1990-06-28	143
K900545	O-RING PROSTHETIC ATTACHMENT DEVICE	Calcitek, Inc.	1990-06-22	137
K852682	CALCITITE BONE GRAFT MAT/ORAL & MAXILLOFACIAL SURG	Calcitek, Inc.	1985-09-23	90
K840750	HYDROXYLAPATITE COATED ENDOSSEOUS DENT	Calcitek, Inc.	1984-04-13	50

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda