FDA 510(k) Applications for Medical Device Product Code "EAT"
(Tester, Pulp)

FDA 510(k) Number Applicant Device Name Decision Date
K820598 ANALYTIC TECHNOLOGY HOT & COLD PULP TESTER #4001 03/19/1982
K790799 ANALYTIC TECHNOLOGY PULPTESTER MODEL 2001 05/31/1979
K011666 HEATSHIELD, INC. CHILLIT 08/06/2001
K870118 LIFE-TECH INTL., INC. MODEL 6110B DENTAPHOR 04/10/1987
K872039 LIFE-TECH INTL., INC. MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS 11/13/1987
K830105 NORTH PACIFIC DENTAL, INC. VITATHYL 03/01/1983
K950237 PARKELL, INC. DIGITEST 06/09/1995
K950238 PARKELL, INC. GENTAL PULSE 05/09/1995
K022097 PARKELL, INC. THERMIQUE 09/06/2002
K012427 SPECIALITES SEPTODONT PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT 10/09/2001
K973439 SYBRON DENTAL SPECIALTIES, INC. ENDO ANALYZER, MODEL 8005 12/08/1997
K990225 SYBRON DENTAL SPECIALTIES, INC. ENDO ANALYZER, MODEL 8005, MODIFIED 02/25/1999
K970715 SYBRON DENTAL SPECIALTIES, INC. SYSTEM B HEAT SOURCE 04/07/1997
K963862 SYBRON DENTAL SPECIALTIES, INC. TOUCH N' HEAT 12/02/1996
K021298 SYBRON ENDO/ANALYTIC ELEMENTS DIAGNOSTIC UNIT 06/19/2002
K800138 TAMLER-STONEHAM INSTRUMENTS TS-301 THREE-WAY PULP TESTER 02/13/1980
K873644 THE HYGENIC CORP. "PULP PEN" 10/27/1987
K881826 THE HYGENIC CORP. ENDO-ICE 08/23/1988
K930764 THE HYGENIC CORP. ENDO-ICE-PULP TESTER-THERMAL 05/27/1993
K883804 THE INSTITUTE FOR TECHNOLOGY DEVELOPMENT E-MITT (CONDUCTIVE HAND COVER) 07/31/1989
K960799 ULTIMATE WIREFORMS, INC. ORTHO-ICE 05/09/1996
K940260 UNION BROACH, DIV. MOYCO INDUSTRIES, INC. THERMAL PULP TESTER 03/07/1994


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