FDA.reportPublic FDA data

510(k) K943584

Device
PRESTERILIZED ENDODONTIC FILES
Applicant
Dentsply Intl.
510(k) number
K943584
Product code
EKJ
Decision
Substantially Equivalent (SESE)
Decision date
1994-09-21
Date received
1994-07-22
Regulation
872.4565
Classification name
Burnisher, Operative
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
P. JEFFREY LEHN
Address
570 W. College Ave. P.O. Box 872 York PA US 17405 17405

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EKJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K961714ASEPTYLUM, UNI-CARRIERDistriflor S.A.1996-06-10
K953707MEDTROL DENTAL KITMedtrol, Inc.1996-01-04
K945815DENTAL KITConstancy Ent., Inc.1995-07-19
K951607SUREFLEX FILESDentsply Intl.1995-06-22
K945077INSTRUMENT,FILLING,PLASTIC,DENTALWorldwide Dental, Inc.1994-11-30
K943820STAT PAKMagnum Instruments, Inc.1994-11-02
K943351MAUNAL DISPOSABLE DENTAL INSTRUMENTSMagnum Instruments, Inc.1994-10-07
K935127SOUTHLAND STERILE DENTAL SYSTEMSouthland, Ltd.1994-07-28
K941954NON-FOGGING DENTAL MIRRORBuffalo Dental Mfg. Co., Inc.1994-07-08
K925115AMD DENTIST AND HYGIENIST KITSAdvance Medical Designs, Inc.1994-07-05
K925889FORCEPS, DRESSING, DENTALProtector, Inc.1994-02-15
K925888EXPLORER, OPERATIVEProtector, Inc.1994-02-15
K925890MIRROR, MOUTHProtector, Inc.1994-02-15
K935217LC DENTAL HAND INSTRUMENTL.C. Dental1994-01-05
K932511SILICONE MIRRORMoyco Industries, Inc.1993-11-05