FDA.reportPublic FDA data

510(k) K011666

Device
CHILLIT
Applicant
Heatshield, Inc.
510(k) number
K011666
Product code
EAT
Decision
Substantially Equivalent (SESE)
Decision date
2001-08-06
Date received
2001-05-30
Regulation
872.1720
Classification name
Tester, Pulp
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
WILLIAM A PLOUMIS
Address
110 Lockwood Ave. Suite 400 New Rochelle NY US 10801 10801

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EAT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K022097THERMIQUEParkell, Inc.2002-09-06
K021298ELEMENTS DIAGNOSTIC UNITSybron Endo/Analytic2002-06-19
K012427PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENTSpecialites Septodont2001-10-09
K990225ENDO ANALYZER, MODEL 8005, MODIFIEDSybron Dental Specialties, Inc.1999-02-25
K973439ENDO ANALYZER, MODEL 8005Sybron Dental Specialties, Inc.1997-12-08
K970715SYSTEM B HEAT SOURCESybron Dental Specialties, Inc.1997-04-07
K963862TOUCH N' HEATSybron Dental Specialties, Inc.1996-12-02
K960799ORTHO-ICEUltimate Wireforms, Inc.1996-05-09
K950237DIGITESTParkell, Inc.1995-06-09
K950238GENTAL PULSEParkell, Inc.1995-05-09
K940260THERMAL PULP TESTERUnion Broach, Div. Moyco Industries, Inc.1994-03-07
K930764ENDO-ICE-PULP TESTER-THERMALThe Hygenic Corp.1993-05-27
K883804E-MITT (CONDUCTIVE HAND COVER)The Institute For Technology Development1989-07-31
K881826ENDO-ICEThe Hygenic Corp.1988-08-23
K872039MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESISLife-Tech Intl., Inc.1987-11-13