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

EAT — Predicate Candidate Screening

22 FDA 510(k) clearances under this product code; the 50 most recent screened below.

70 daysmedian FDA review time

140 days90th percentile

22clearances measured

K-number	Device	Applicant	Decided	Review days
K022097	THERMIQUE	Parkell, Inc.	2002-09-06	71
K021298	ELEMENTS DIAGNOSTIC UNIT	Sybron Endo/Analytic	2002-06-19	56
K012427	PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT	Specialites Septodont	2001-10-09	70
K011666	CHILLIT	Heatshield, Inc.	2001-08-06	68
K990225	ENDO ANALYZER, MODEL 8005, MODIFIED	Sybron Dental Specialties, Inc.	1999-02-25	31
K973439	ENDO ANALYZER, MODEL 8005	Sybron Dental Specialties, Inc.	1997-12-08	89
K970715	SYSTEM B HEAT SOURCE	Sybron Dental Specialties, Inc.	1997-04-07	39
K963862	TOUCH N' HEAT	Sybron Dental Specialties, Inc.	1996-12-02	69
K960799	ORTHO-ICE	Ultimate Wireforms, Inc.	1996-05-09	72
K950237	DIGITEST	Parkell, Inc.	1995-06-09	140
K950238	GENTAL PULSE	Parkell, Inc.	1995-05-09	109
K940260	THERMAL PULP TESTER	Union Broach, Div. Moyco Industries, Inc.	1994-03-07	45
K930764	ENDO-ICE-PULP TESTER-THERMAL	The Hygenic Corp.	1993-05-27	104
K883804	E-MITT (CONDUCTIVE HAND COVER)	The Institute For Technology Development	1989-07-31	327
K881826	ENDO-ICE	The Hygenic Corp.	1988-08-23	116
K872039	MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS	Life-Tech Intl., Inc.	1987-11-13	170
K873644	PULP PEN	The Hygenic Corp.	1987-10-27	48
K870118	MODEL 6110B DENTAPHOR	Life-Tech Intl., Inc.	1987-04-10	88
K830105	VITATHYL	North Pacific Dental, Inc.	1983-03-01	49
K820598	HOT & COLD PULP TESTER #4001	Analytic Technology	1982-03-19	15
K800138	TS-301 THREE-WAY PULP TESTER	Tamler-Stoneham Instruments	1980-02-13	23
K790799	PULPTESTER MODEL 2001	Analytic Technology	1979-05-31	37

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