Unit, X-Ray, Intraoral
FDA product code EAP · Class II (moderate risk) · 21 CFR 872.1810 · Dental
42510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Belmont Equipment Corp. 5
- Keystone X-Ray, Inc. 3
- Trophy Radiologie 3
- Pelton & Crane Co. 3
- Schick Technologies, Inc. 3
- Pennwalt Corp. 2
- General Electric Co. 2
- Chicago X-Ray Systems, Inc. 2
- Mdt Corp., Inc. 1
- Siemens Corp. 1
- Precise Optics 1
- Dentomar, Inc. 1
- The S. S. White Co. 1
- Mdt Diagnostic Co. 1
- Tempo Technology, Inc. 1
- Healthpak, Inc. 1
- Afp Imaging Corp. 1
- Kaycor Intl., Ltd. 1
- Xerox Medical Systems 1
- Humanray Co,Ltd 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K113360 | Medical Image Processing UnitEAP · Special | Humanray Co,Ltd | 02/07/2012SE |
| K102573 | Provu (TM) Dental X-Ray SystemEAP · Traditional | Advanced Image Science, Inc. | 06/30/2011SE |
| K093453 | Modification to Computed Oral Radiology SystemEAP · Special | Schick Technologies, Inc. | 11/30/2009SE |
| K080738 | Dentron SensorEAP · Traditional | Dentron Systems, LLC | 05/13/2008SE |
| K052422 | The Envision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile)EAP · Special | Flow X-Ray Corp. | 09/27/2005SE |
| K041385 | Modification to Computed Oral Radiology SystemEAP · Special | Schick Technologies, Inc. | 06/07/2004SE |
| K960819 | Heliodent DSEAP · Traditional | Pelton & Crane Co. | 03/29/1996SE |
| K960028 | Orthoralix SD2 & S Panoramic Dental X-Ray SystemEAP · Traditional | Dentsply Intl. | 03/01/1996SE |
| K953936 | AtlantisEAP · Traditional | Trophy Radiologie | 12/28/1995SE |
| K954565 | Explor-X (Azteh) HFEAP · Traditional | Chicago X-Ray Systems, Inc. | 10/27/1995SE |
| K951734 | Lumix 70BEAP · Traditional | Emix U.S.A., Inc. | 07/20/1995SE |
| K950533 | Trophy Radiologie RVG RadiovisiographyEAP · Traditional | Trophy Radiologie | 06/30/1995SE |
| K950532 | Trophy Radiologie RVG Portable RadiovisiographyEAP · Traditional | Trophy Radiologie | 04/19/1995SE |
| K950667 | Aztech 65 with CCD (Computer Controlled Density) TimerEAP · Traditional | Chicago X-Ray Systems, Inc. | 04/06/1995SE |
| K950030 | Heliodent MDEAP · Traditional | Pelton & Crane Co. | 02/03/1995SE |
| K934645 | RadworksEAP · Traditional | Radworks Corp. | 08/17/1994SE |
| K936068 | Orthophos 3/ Orthophos 3CEAP · Traditional | Pelton & Crane Co. | 07/29/1994SE |
| K933455 | Computed Oral Radiology SystemEAP · Traditional | Schick Technologies, Inc. | 01/31/1994SE |
| K931486 | Intrex VSK Interoral Dental X-Ray UnitEAP · Traditional | Keystone X-Ray, Inc. | 11/23/1993SE |
| K931717 | Yoshida/Kaycor X-707 Wall Mounted Dental X-RayEAP · Traditional | Kaycor Intl., Ltd. | 09/20/1993SE |
| K930925 | Intrex Interoral Dental X-Ray UnitEAP · Traditional | Keystone X-Ray, Inc. | 07/13/1993SE |
| K930761 | Image-X 70 Intraoral X-Ray SystemEAP · Traditional | Afp Imaging Corp. | 05/25/1993SE |
| K923307 | Healthpak X-Ray Sox BarriersEAP · Traditional | Healthpak, Inc. | 01/21/1993SE |
| K900681 | Panoramic Model X-Caliber X-RayEAP · Traditional | Belmont Equipment Corp. | 05/23/1990SE |
| K896963 | Trimode SP Dental Intra Oral X-RayEAP · Traditional | Tempo Technology, Inc. | 01/22/1990SE |
| K896024 | Mdt/Castle Model HDX Dental X-Ray MachineEAP · Traditional | Mdt Diagnostic Co. | 01/22/1990SE |
| K883354 | Variable KV Intrex VSK 60 - 90 KVPEAP · Traditional | Keystone X-Ray, Inc. | 12/21/1988SE |
| K882379 | Minim-X 2001-CIAS & Minim-X 2002-CIASEAP · Traditional | Dentomar, Inc. | 09/09/1988SE |
| K861328 | New Belmont Model, MC-5 Dental, Intraoral X-RayEAP · Traditional | Belmont Equipment Corp. | 04/24/1986SE |
| K852019 | Belmont Autopan-Pan Oramic, 098E Cephalometric-RadEAP · Traditional | Belmont Equipment Corp. | 06/05/1985SE |
| K834279 | Acuray 071A Dental Intraoral X-RayEAP · Traditional | Belmont Equipment Corp. | 12/29/1983SE |
| K833241 | IntrexEAP · Traditional | Pennwalt Corp. | 10/28/1983SE |
| K832065 | Acuracy 071, Dental, Intraoral-X-RayEAP · Traditional | Belmont Equipment Corp. | 09/12/1983SE |
| K800063 | XR-710EAP · Traditional | Pennwalt Corp. | 03/03/1980SE |
| K792535 | PortarayEAP · Traditional | Siemens Corp. | 01/28/1980SE |
| K792437 | Raflex 70EAP · Traditional | Mdt Corp., Inc. | 01/09/1980SE |
| K792307 | Dentix Dental X-Ray UnitEAP · Traditional | Precise Optics | 01/09/1980SE |
| K791014 | Dental XeroradiographyEAP · Traditional | Xerox Medical Systems | 09/04/1979SE |
| K781630 | GE-700 Intra Oral X-Ray SystemEAP · Traditional | General Electric Co. | 12/04/1978SE |
| K772184 | X-Ray System for Dental ApplicationEAP · Traditional | General Electric Co. | 12/22/1977SE |
| K770345 | X-Ray Tube - PanobeamEAP · Traditional | Thoro-Ray, Inc. | 03/08/1977SE |
| K760323 | X-Ray Unit, Dental DiagnosticEAP · Traditional | The S. S. White Co. | 08/03/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1020-2013 Class II | DeGotzen XRay unit XGenus Dental X-ray unit.It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification | DeGotzen | 09/26/2012Terminated |
| Z-1095-2013 Class II | CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The expected usage…There have been approximately 2% of the x-ray generators manufactured between February 2012 and November… | Trophy Sas | 09/18/2012Terminated |
| Z-1094-2013 Class II | CareStream Dental Kodak 2100 Intraoral X-ray system Product Usage: The expected usage…There have been approximately 2% of the x-ray generators manufactured between February 2012 and November… | Trophy Sas | 09/18/2012Terminated |
| Z-1000-2013 Class II | CareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended use)…There have been approximately 2% of the x-ray generators manufactured between February 2012 and November… | Trophy Sas | 09/18/2012Terminated |
| Z-0999-2013 Class II | CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use)…There have been approximately 2% of the x-ray generators manufactured between February 2012 and November… | Trophy Sas | 09/18/2012Terminated |
| Z-1179-2013 Class II | Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray…The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR 1010.2 &… | Chicago X-Ray Systems, Inc. | 07/03/2012Terminated |