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

FDA 510(k) Number Applicant Device Name Decision Date
K011666 HEATSHIELD, INC. CHILLIT 08/06/2001
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
K960799 ULTIMATE WIREFORMS, INC. ORTHO-ICE 05/09/1996


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