Unit, X-Ray, Intraoral
Regulation 872.1810
0510(k)s in 12 months (42 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in EAP
| Company | 510(k)s | Recalls |
|---|---|---|
| Belmont Equipment Corp. | 5 | 0 |
| Trophy Sas | 0 | 4 |
| Chicago X-Ray Systems, Inc. | 2 | 1 |
| Keystone X-Ray, Inc. | 3 | 0 |
| Pelton & Crane Co. | 3 | 0 |
| Schick Technologies, Inc. | 3 | 0 |
| Trophy Radiologie | 3 | 0 |
| General Electric Co. | 2 | 0 |
| Pennwalt Corp. | 2 | 0 |
| Advanced Image Science, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2013 | Chicago X-Ray Systems, Inc. Fona Srl IntraOs 70 intra-oral x-ray system
IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth. Terminated |
EAP | None listed |
| May 2, 2013 | Trophy Sas CareStream Dental Kodak 2200 Intraoral X-ray system
Product Usage:
The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw a Terminated |
EAP | None listed |
| May 2, 2013 | Trophy Sas CareStream Dental Kodak 2100 Intraoral X-ray system
Product Usage:
The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw a Terminated |
EAP | None listed |
| May 2, 2013 | Trophy Sas CareStream Dental CS 2200 X-ray system
Product Usage:
The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral stru Terminated |
EAP | None listed |
| May 2, 2013 | Trophy Sas CareStream Dental CS 2100 X-ray system
Product Usage:
The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral struc Terminated |
EAP | None listed |
| Apr 17, 2013 | DeGotzen DeGotzen XRay unit XGenus
Dental X-ray unit. Terminated |
EAP | None listed |
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