Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart B — Diagnostic Devices](/submissions/DE/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 872.1810](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1810) → EAP — Unit, X-Ray, Intraoral # EAP · Unit, X-Ray, Intraoral _Dental · 21 CFR 872.1810 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP ## Overview - **Product Code:** EAP - **Device Name:** Unit, X-Ray, Intraoral - **Regulation:** [21 CFR 872.1810](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1810) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **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](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP/K113360.md) | MEDICAL IMAGE PROCESSING UNIT | Humanray Co,Ltd | Feb 7, 2012 | SESE | | [K102573](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP/K102573.md) | PROVU (TM) DENTAL X-RAY SYSTEM | Advanced Image Science, Inc. | Jun 30, 2011 | SESE | | [K093453](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP/K093453.md) | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | Schick Technologies, Inc. | Nov 30, 2009 | SESE | | [K080738](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP/K080738.md) | DENTRON SENSOR | Dentron Systems, LLC | May 13, 2008 | SESE | | [K052422](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP/K052422.md) | THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) | Flow X-Ray Corp. | Sep 27, 2005 | SESE | | [K041385](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP/K041385.md) | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | Schick Technologies, Inc. | Jun 7, 2004 | SESE | | [K960819](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP/K960819.md) | HELIODENT DS | Pelton & Crane Co. | Mar 29, 1996 | SESE | | [K960028](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP/K960028.md) | ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM | Dentsply Intl. | Mar 1, 1996 | SESE | | [K953936](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP/K953936.md) | ATLANTIS | Trophy Radiologie | Dec 28, 1995 | SESE | | [K954565](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP/K954565.md) | EXPLOR-X (AZTEH) HF | Chicago X-Ray Systems, Inc. | Oct 27, 1995 | SESE | | [K951734](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP/K951734.md) | LUMIX 70B | Emix U.S.A., Inc. | Jul 20, 1995 | SESE | | [K950533](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP/K950533.md) | TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY | Trophy Radiologie | Jun 30, 1995 | SESE | | [K950532](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP/K950532.md) | TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY | Trophy Radiologie | Apr 19, 1995 | SESE | | [K950667](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP/K950667.md) | AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER | Chicago X-Ray Systems, Inc. | Apr 6, 1995 | SESE | | [K950030](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP/K950030.md) | HELIODENT MD | Pelton & Crane Co. | Feb 3, 1995 | SESE | | [K934645](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP/K934645.md) | RADWORKS | Radworks Corp. | Aug 17, 1994 | SESE | | [K936068](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP/K936068.md) | ORTHOPHOS 3/ ORTHOPHOS 3C | Pelton & Crane Co. | Jul 29, 1994 | SESE | | [K933455](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP/K933455.md) | COMPUTED ORAL RADIOLOGY SYSTEM | Schick Technologies, Inc. | Jan 31, 1994 | SESE | | [K931486](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP/K931486.md) | INTREX VSK INTERORAL DENTAL X-RAY UNIT | Keystone X-Ray, Inc. | Nov 23, 1993 | SESE | | [K931717](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP/K931717.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EAP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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