Company ยท US
Gendex Dental Systems
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2006. Name variants (Inc, Corp, punctuation) are merged.
2510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2012 | Gendex Dental Systems Gendex eXpert DC Intraoral Dental X-Ray System
Device is to be used as an extra-oral source of X-Rays in Dental Radiography Terminated |
EHD | K992610 |
| Apr 22, 2011 | Gendex Dental Systems Orthoralix 9200 DDE Panoramic and Cephalometric Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; Part numbers 110-0199G2, 110-0199G4, 110-0234G1 and Terminated |
EHD | K032355 |
| Apr 22, 2011 | Gendex Dental Systems Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part numbers 110-0199G2, 110-0199G4, 110-0234G1 and 110-0234G3.
The Terminated |
EHD | K050255 |
| Mar 4, 2011 | Gendex Dental Systems Wall Mounting Plate, an accessory to the Gendex eXpert DC (REF 110-0205G1) and 765DC (REF 110-0155G1)Intraoral X-Ray Systems; Gendex Dental Systems, Des Plaines, IL USA
The wall mounting plate is use Terminated |
EHD | K992610 |
| Feb 18, 2011 | Gendex Dental Systems Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part number 110-0234G1 (domestic) and 110-0234G3 (international)
The O Terminated |
EHD | K050255 |
| Feb 15, 2011 | Gendex Dental Systems Gendex Dental Systems, Gendex eXpert DC Intraoral X-Ray System; a dental x-ray system; Model 110-0205G1, catalog number EXPERTDC75NA Terminated |
EHD | K992610 |
| Jul 17, 2009 | Gendex Dental Systems Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Gendex Dental Systems, 901 West Oakton Street, Des Plaines, IL 60018.
Intended for use of the software is to control capture, displ Terminated |
MUH | K060178 |