EAP · Unit, X-Ray, Intraoral
Dental · 21 CFR 872.1810 · Class 2
Overview
| Product Code | EAP |
|---|---|
| Device Name | Unit, X-Ray, Intraoral |
| Regulation | 21 CFR 872.1810 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
An intraoral source x-ray system is an electrically powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located inside the mouth. This generic type of device may include patient and equipment supports and component parts.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 42)
Showing 20 most recent of 42 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K113360 | MEDICAL IMAGE PROCESSING UNIT | Humanray Co,Ltd | Feb 7, 2012 | SESE |
| K102573 | PROVU (TM) DENTAL X-RAY SYSTEM | Advanced Image Science, Inc. | Jun 30, 2011 | SESE |
| K093453 | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | Schick Technologies, Inc. | Nov 30, 2009 | SESE |
| K080738 | DENTRON SENSOR | Dentron Systems, LLC | May 13, 2008 | SESE |
| K052422 | THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) | Flow X-Ray Corp. | Sep 27, 2005 | SESE |
| K041385 | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | Schick Technologies, Inc. | Jun 7, 2004 | SESE |
| K960819 | HELIODENT DS | Pelton & Crane Co. | Mar 29, 1996 | SESE |
| K960028 | ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM | Dentsply Intl. | Mar 1, 1996 | SESE |
| K953936 | ATLANTIS | Trophy Radiologie | Dec 28, 1995 | SESE |
| K954565 | EXPLOR-X (AZTEH) HF | Chicago X-Ray Systems, Inc. | Oct 27, 1995 | SESE |
| K951734 | LUMIX 70B | Emix U.S.A., Inc. | Jul 20, 1995 | SESE |
| K950533 | TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY | Trophy Radiologie | Jun 30, 1995 | SESE |
| K950532 | TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY | Trophy Radiologie | Apr 19, 1995 | SESE |
| K950667 | AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER | Chicago X-Ray Systems, Inc. | Apr 6, 1995 | SESE |
| K950030 | HELIODENT MD | Pelton & Crane Co. | Feb 3, 1995 | SESE |
| K934645 | RADWORKS | Radworks Corp. | Aug 17, 1994 | SESE |
| K936068 | ORTHOPHOS 3/ ORTHOPHOS 3C | Pelton & Crane Co. | Jul 29, 1994 | SESE |
| K933455 | COMPUTED ORAL RADIOLOGY SYSTEM | Schick Technologies, Inc. | Jan 31, 1994 | SESE |
| K931486 | INTREX VSK INTERORAL DENTAL X-RAY UNIT | Keystone X-Ray, Inc. | Nov 23, 1993 | SESE |
| K931717 | YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY | Kaycor Intl., Ltd. | Sep 20, 1993 | SESE |
Top Applicants
- Belmont Equipment Corp. — 5 clearances
- Keystone X-Ray, Inc. — 3 clearances
- Pelton & Crane Co. — 3 clearances
- Schick Technologies, Inc. — 3 clearances
- Trophy Radiologie — 3 clearances
