Unit, X-Ray, Extraoral With Timer
Regulation 872.1800
6510(k)s in 12 months (191 all time)
0recalls in 12 months (18 all time)
17recalls that name a 510(k)
Top companies in EHD
| Company | 510(k)s | Recalls |
|---|---|---|
| Planmeca Oy | 14 | 0 |
| Digimed Co., Ltd. | 6 | 1 |
| Gendex Dental Systems | 1 | 6 |
| Villa Sistemi Medicali S.P.A. | 7 | 0 |
| Trophy Radiologie | 6 | 0 |
| VATECH Co., Ltd. | 6 | 0 |
| Aribex | 3 | 2 |
| Dentsply Intl. | 4 | 0 |
| Gendex Corp. | 3 | 1 |
| Instrumentarium Corp. | 4 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2025 | DIGIMED CO., LTD Portable X-ray system Open, Classified |
EHD | K082167 |
| Jan 9, 2018 | Panoramic Rental Corp. PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3 Terminated |
EHD | K870236 K882436 |
| Sep 2, 2016 | Aribex Inc NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, Part Number 08500022; NOMAD Pro2 Vet Packaged X-Ray System, Part Number 08500023; NOMAD Pro2 Vet Package Terminated |
EHD | K081664 |
| Sep 2, 2016 | Aribex Inc NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number 08500011; NOMAD Pro Packaged X-Ray System - Europe, Part Number 08500013; NOMAD Pro X-Ray System Terminated |
EHD | K081664 |
| Aug 19, 2016 | Panoramic Rental Corp. Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate
Product Usage:
The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panorami Terminated |
EHD | K870236 K882436 |
| Sep 1, 2015 | Panoramic Rental Corp. Panoramic X-ray Model PC-1000
The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser 1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ra Terminated |
EHD | K870236 K882436 |
| 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 | K992610 |
| Mar 4, 2014 | Carestream Health Inc. Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. Made in France --
--- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICAT Terminated |
EHD | K060292 |
| Mar 4, 2014 | Carestream Health Inc. Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/ Terminated |
EHD | K060292 |
| Feb 25, 2014 | Instrumentarium Dental, PaloDEx Group Oy The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOC Terminated |
EHD | K022630 |
| May 23, 2013 | CEFLA DENTAL GROUP MyRay RXDC dental unit
x-ray unit 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 | 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 20, 2004 | Philips Medical Systems Sales & Service Region No. America Clea Stand Ceiling used with the Integris X-Ray System H5000, Allura 12/15, Allura 9C Terminated |
EHD | K971365 |
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