FDA.reportPublic FDA data

510(k) K873644

Device
Pulp Pen
Applicant
THE HYGENIC CORP.
510(k) number
K873644
Product code
EAT
Decision
Substantially Equivalent (SESE)
Decision date
1987-10-27
Date received
1987-09-09
Regulation
872.1720
Classification name
Tester, Pulp
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
T. N MEYER
Address
1245 Home Ave. Akron OH US 44310 44310

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
K011666CHILLITHeatshield, Inc.2001-08-06
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