510(k) K992610 ยท EHD Unit, X-Ray, Extraoral With Timer
GENDEX 765DC, MODEL 110-0154
| Applicant | Dentsply Intl., Des Plaines IL, US |
| Decision | Substantially Equivalent, Sep 7, 1999 |
| Received | Aug 4, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992610
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2014 | Gendex Corp eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 5 Terminated |
EHD | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.