FDA.reportPublic FDA data

510(k) K972985

Device
SPLINT IT
Applicant
JENERIC/PENTRON, INC.
510(k) number
K972985
Product code
ELS  
Decision
Substantially Equivalent (SESE)
Decision date
1997-09-24
Date received
1997-08-11
Regulation
872.3890
Classification name
Splint, Endodontic Stabilizing
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MURRAY G GAMBERG
Address
53 N. Plains Industrial Rd. P.O. Box 724 Wallingford CT US 06492 06492

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ELS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K961704MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEMDentatus USA , Ltd.1996-07-26
K922673FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDINGGlasspan, Inc.1994-02-25
K834363ENDIX RADICULAR BIOCERAMIC PINC.B.S. Biotechnics, Inc.1984-02-27
K811209JACOB WIRZ TRANSFIXATION PINColmed, Ltd.1981-06-16
K801525ZEST ENDODONTIC STABILIZERZest Anchors, Inc.1980-07-21

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases