Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Centrix, Inc. — Predicate Candidate Screening

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

84 daysmedian FDA review time

238 days90th percentile

47clearances measured

K-number	Device	Applicant	Decided	Review days
K250714	FluoroDose Varnish	Centrix, Inc.	2025-11-21	256
K222459	Centrix FluoroSilver Silver Diamine Fluoride 38%	Centrix, Inc.	2023-10-27	438
K152826	NoCord	Centrix, Inc.	2016-05-27	241
K140144	BENDA WEDGE	Centrix, Inc.	2014-07-08	167
K120176	SENZZZZZ AWAY	Centrix, Inc.	2012-07-25	187
K111348	RE / STASIS (TM) GINGIVAL RETRACTION PASTE	Centrix, Inc.	2011-07-22	70
K092384	LIQUICORD	Centrix, Inc.	2009-11-04	91
K091380	CORDCAP	Centrix, Inc.	2009-07-30	80
K021131	CHLORAPREP	Centrix, Inc.	2002-09-26	171
K021146	D/SENSE 1-STEP	Centrix, Inc.	2002-07-02	84
K010133	VERSALUX	Centrix, Inc.	2001-04-05	78
K001050	CALCIJECT	Centrix, Inc.	2000-07-21	112
K992629	D/SENSE II (GREEN-OR) DENTIN DESENSITIZER	Centrix, Inc.	1999-10-22	86
K981972	GREEN-OR DENTIN DESENSITIZER	Centrix, Inc.	1998-12-07	186
K982665	JUMBO SILVER-REINFORCED GLASS IONOMER	Centrix, Inc.	1998-09-08	46
K980568	JUMBO GLASS IONOMER CEMENT	Centrix, Inc.	1998-04-30	80
K973285	D/SENSE-T	Centrix, Inc.	1998-02-25	176
K973257	VERSAETCH	Centrix, Inc.	1997-11-17	80
K971121	ENCORE BOND	Centrix, Inc.	1997-06-27	92
K965138	DENTINSENSE B/C	Centrix, Inc.	1997-02-14	53
K964735	DENTINSENSE	Centrix, Inc.	1997-02-05	72
K963927	TEAM CARIES INDICATOR	Centrix, Inc.	1996-11-15	66
K963311	TEAM ETCH	Centrix, Inc.	1996-10-07	46
K961190	GLY-ETCH	Centrix, Inc.	1996-04-23	28
K955279	D-SENSE	Centrix, Inc.	1995-12-28	42
K952728	RETRAC	Centrix, Inc.	1995-09-29	107
K935151	HYDROCOLLOID HEATING UNIT	Centrix, Inc.	1994-04-04	158
K933507	NEEDLETUBE SYRINGE CARTRTIDGE	Centrix, Inc.	1994-01-18	187
K933999	STERIBASE (ACCUBASE)	Centrix, Inc.	1994-01-05	141
K926368	APPLICATOR NOZZLE	Centrix, Inc.	1993-09-15	267
K931084	TEMPIT	Centrix, Inc.	1993-05-27	86
K921173	TYPE 1 DENTAL CEMENT	Centrix, Inc.	1992-11-04	238
K921174	COMPOSITE RESIN CORE PASTE MATERIAL	Centrix, Inc.	1992-09-01	174
K922638	TEMPIT-E	Centrix, Inc.	1992-08-10	97
K913974	ACCESS IMPRESSION BARREL	Centrix, Inc.	1992-02-25	172
K890140	PHOSPHORIC-ACID ETCHING GEL	Centrix, Inc.	1989-03-29	75
K890064	DENTAL SYRINGE APPLICATION TIP	Centrix, Inc.	1989-02-10	32
K885162	BENDA BRUSH	Centrix, Inc.	1989-01-10	28
K882125	CENTRIX TRI-LAMINATE POST SYSTEM	Centrix, Inc.	1988-08-11	83
K882651	CENTRIX NEEDLETUBE	Centrix, Inc.	1988-08-10	44
K873002	MIN-IDENTOFLEX	Centrix, Inc.	1987-08-17	13
K861581	CENTRIX PCR MOLAR MATRIX FORMS (BANDS)	Centrix, Inc.	1986-05-12	13
K853282	CENTRIX RIBBON TUBES	Centrix, Inc.	1985-08-23	18
K833725	PRE-LOADED C-R TUBES FOR SYRINGE	Centrix, Inc.	1984-03-30	158
K832662	DENTAL SYRINGE SYSTEM-VARIOUS STYLES	Centrix, Inc.	1983-10-04	57
K811831	MULTI-PURPOSE DENTAL SYRINGE	Centrix, Inc.	1981-09-08	71
K792461	CENTRIX MKIV ENDODONTIC DELIVERY	Centrix, Inc.	1979-12-19	16

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