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

Parkell, Inc. — Predicate Candidate Screening

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

72 daysmedian FDA review time

148 days90th percentile

53clearances measured

K-number	Device	Applicant	Decided	Review days
K243254	Parkell Pit and Fissure Sealant	Parkell, Inc.	2025-08-08	297
K210259	Parkell Self-Adhesive Cement	Parkell, Inc.	2022-01-20	353
K191103	Parkell Desensitizer Gel	Parkell, Inc.	2019-11-22	211
K190930	SmarTemp X1	Parkell, Inc.	2019-09-05	148
K182296	HyperFil-LV	Parkell, Inc.	2018-12-14	112
K172176	Parkell Universal Adhesive	Parkell, Inc.	2017-11-21	125
K151518	BRUSH&BOND PLUS	Parkell, Inc.	2015-09-18	105
K142848	EAZY PRIMER	Parkell, Inc.	2015-02-24	147
K132115	ABSOLUTE DENTIN 2	Parkell, Inc.	2014-06-25	351
K113839	RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE	Parkell, Inc.	2012-04-12	106
K101044	RETRIEVE IMPLANT CEMENT	Parkell, Inc.	2010-06-10	57
K080549	DURAFINISH ALL-CURE, MODEL S296	Parkell, Inc.	2008-05-13	76
K073698	SECURE	Parkell, Inc.	2008-03-19	79
K062518	CELERITY	Parkell, Inc.	2006-12-04	98
K063003	AURORA	Parkell, Inc.	2006-11-28	57
K060946	CZ-S2000	Parkell, Inc.	2006-06-15	70
K053516	MUCOHARD	Parkell, Inc.	2006-01-26	41
K040599	PARKELL RESIN GLAZE	Parkell, Inc.	2004-04-09	32
K032179	COMP. E	Parkell, Inc.	2003-09-09	57
K031212	TEMPORARY RESIN CEMENT	Parkell, Inc.	2003-07-11	85
K022097	THERMIQUE	Parkell, Inc.	2002-09-06	71
K020239	TOUCH&BOND-PLUS	Parkell, Inc.	2002-03-20	56
K012360	LC TEMPORARY FILLING	Parkell, Inc.	2001-09-06	43
K010475	D/C CORE MATERIAL	Parkell, Inc.	2001-05-07	76
K002195	FORAMATRON V, MODEL D680	Parkell, Inc.	2000-08-30	41
K994302	RESIN TOOTH BONDING AGENT	Parkell, Inc.	2000-02-07	48
K991270	SMARTEMP	Parkell, Inc.	1999-05-21	38
K990381	TOTALBOND	Parkell, Inc.	1999-05-17	98
K983413	MODEL MS-1 HANDPIECE	Parkell, Inc.	1998-12-21	84
K982050	MODEL MS-2 HANDPIECE	Parkell, Inc.	1998-09-02	83
K974865	CSR	Parkell, Inc.	1998-03-16	77
K973679	AEROETCHER	Parkell, Inc.	1998-03-10	165
K973976	EPIC-FLO	Parkell, Inc.	1997-12-04	45
K973200	CARIES STAIN	Parkell, Inc.	1997-11-06	72
K972421	EASY BOND	Parkell, Inc.	1997-08-29	63
K964867	HYBRID RESIN COMPOSITE	Parkell, Inc.	1997-04-11	127
K962741	TRI-PHASIX CHROMATIC ALGINATE	Parkell, Inc.	1996-09-06	53
K960879	AMALGAMIBOND PLUS	Parkell, Inc.	1996-03-22	18
K960464	C & B METABOND (MODIFICATION)	Parkell, Inc.	1996-02-26	27
K952123	MS EMULSION	Parkell, Inc.	1995-06-20	46
K952124	ABOND	Parkell, Inc.	1995-06-20	46
K950237	DIGITEST	Parkell, Inc.	1995-06-09	140
K950239	SENSIMATIC 500SE	Parkell, Inc.	1995-06-06	137
K950238	GENTAL PULSE	Parkell, Inc.	1995-05-09	109
K950857	FORAMATRON IV	Parkell, Inc.	1995-04-20	52
K950905	C&B-METABOND RADIOPAQUE POWDER	Parkell, Inc.	1995-04-10	41
K950240	LE CLEAN MACHINE	Parkell, Inc.	1995-04-04	74
K950256	TURBO 25/30	Parkell, Inc.	1995-04-04	71
K942017	V-PRIMER	Parkell, Inc.	1994-07-06	71
K933547	INTRA-ORAL IRRIGATOR	Parkell, Inc.	1993-10-20	90

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