FDA.reportPublic FDA data

510(k) K833006

Device
Cephalometer & Fixator
Applicant
MODERN SYSTEMS, INC.
510(k) number
K833006
Product code
EAG
Decision
Substantially Equivalent (SESE)
Decision date
1984-01-03
Date received
1983-09-06
Regulation
872.1830
Classification name
Cephalometer
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EAG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K030699VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRICJ. Morita Mfg. Corp.2003-05-29
K021372VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITYJ. Morita USA, Inc.2002-06-07
K944162DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEMTeledyne Water Pik1994-11-29
K920189GX-C CEPHALOMETERGendex Corp.1992-04-28
K896099DIGIGRAPH DIAGNOSTIC WORK/STATIONDolphin Imaging Systems1991-01-31
K870243BURNETT TMJ APPLIANCEMedrad, Inc.1987-02-24
K842463GX CEPHGendex Corp.1984-08-02
K810538PLASTICEPHMorningstar Dental Co.1981-04-29
K781287DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACHSiemens Corp.1978-09-11