FDA.reportPublic FDA data

510(k) K973495

Device
GLENROE GLOW IN DARK ELASTOMERIC LIGATURES
Applicant
GLENROE
510(k) number
K973495
Product code
ECI  
Decision
Substantially Equivalent (SESE)
Decision date
1997-12-01
Date received
1997-09-16
Regulation
872.5410
Classification name
Band, Elastic, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JOHN BOZMAN
Address
1912 44th Ave. E Bradenton FL US 34203 34203

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ECI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K980864POWER COINS GLOW IN THE DARK LIGATURESOrtho Kinetics Corp.1998-04-20
K980053GLENROE CHAINGlenroe Technologies1998-02-24
K943419ORTHODONTIC ELASTOMERIC LAGATURE MODULEJon-Ko Products, Inc.1995-05-24
K943420ORTHODONTIC ELASTOMERIC CHAINJon-Ko Products, Inc.1995-05-23
K943418ORTHODONTIC ELASTOMERIC SEPARATOR MODULEJon-Ko Products, Inc.1995-05-23
K943417ORTHODONTIC ELASTOMERIC TUBE/THREADJon-Ko Products, Inc.1995-05-23
K940165ALASTIKUnitek Corp.1994-03-07
K932298PRO'S NEO-LASTICSProfessional Positioners, Inc.1994-02-14
K935144DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICSDentauraum, Inc.1994-02-04
K932319ORTHODONTIC ELASTOMERGac Intl., Inc.1993-09-20
K931462GLENROE CHAINGlenroe Technologies, Inc.1993-07-22
K923999ALASTIK NSUnitek Corp.1993-06-24
K930453SINGLESNexadental1993-05-27
K924140TUFF TIESGlenroe Technologies1993-04-27
K924139GLENROE ORTHO SEPSGlenroe Technologies1993-04-08

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