Atlas FDA

EAT

22 FDA 510(k) clearances · Product code

70 daysmedian time to decision
140 days90th percentile
22clearances measured

FDA profile

Official device name
Tester, Pulp
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1720
Medical specialty
Dental
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
THERMIQUE (K022097)Parkell, Inc.2002-09-06
ELEMENTS DIAGNOSTIC UNIT (K021298)Sybron Endo/Analytic2002-06-19
PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT (K012427)Specialites Septodont2001-10-09
CHILLIT (K011666)Heatshield, Inc.2001-08-06
ENDO ANALYZER, MODEL 8005, MODIFIED (K990225)Sybron Dental Specialties, Inc.1999-02-25
ENDO ANALYZER, MODEL 8005 (K973439)Sybron Dental Specialties, Inc.1997-12-08
SYSTEM B HEAT SOURCE (K970715)Sybron Dental Specialties, Inc.1997-04-07
TOUCH N' HEAT (K963862)Sybron Dental Specialties, Inc.1996-12-02
ORTHO-ICE (K960799)Ultimate Wireforms, Inc.1996-05-09
DIGITEST (K950237)Parkell, Inc.1995-06-09
GENTAL PULSE (K950238)Parkell, Inc.1995-05-09
THERMAL PULP TESTER (K940260)Union Broach, Div. Moyco Industries, Inc.1994-03-07
ENDO-ICE-PULP TESTER-THERMAL (K930764)The Hygenic Corp.1993-05-27
E-MITT (CONDUCTIVE HAND COVER) (K883804)The Institute For Technology Development1989-07-31
ENDO-ICE (K881826)The Hygenic Corp.1988-08-23
MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS (K872039)Life-Tech Intl., Inc.1987-11-13
PULP PEN (K873644)The Hygenic Corp.1987-10-27
MODEL 6110B DENTAPHOR (K870118)Life-Tech Intl., Inc.1987-04-10
VITATHYL (K830105)North Pacific Dental, Inc.1983-03-01
HOT & COLD PULP TESTER #4001 (K820598)Analytic Technology1982-03-19
TS-301 THREE-WAY PULP TESTER (K800138)Tamler-Stoneham Instruments1980-02-13
PULPTESTER MODEL 2001 (K790799)Analytic Technology1979-05-31

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Every clearance here is in the API, with alerts when new ones post.