Product Code: EAP
FDA class 2
21 CFR 872.1810
Unit, X-Ray, Intraoral
Dental
The Intraoral X-Ray Unit is a dental radiographic device used to produce X-ray images of individual teeth and surrounding bone structures when the image receptor is placed inside the patient's mouth. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is EAP and the applicable regulation is 21 CFR 872.1810, under the Dental medical specialty. This device is eligible for third-party 510(k) review.
510(k)s
42
FEI Numbers
7
Registration Numbers
7
Unique Applicants
27
Years Active
36
Basic Information
- Product Code
- EAP
- Device Class
- FDA class 2
- Regulation Number
- 872.1810
- Medical Specialty
- Dental
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 42 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K113360 | MEDICAL IMAGE PROCESSING UNIT | Feb 07, 2012 | Substantially Equivalent | HUMANRAY CO,LTD |
| K102573 | PROVU (TM) DENTAL X-RAY SYSTEM | Jun 30, 2011 | Substantially Equivalent | ADVANCED IMAGE SCIENCE, INC. |
| K093453 | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | Nov 30, 2009 | Substantially Equivalent | SCHICK TECHNOLOGIES, INC. |
| K080738 | DENTRON SENSOR | May 13, 2008 | Substantially Equivalent | DENTRON SYSTEMS LLC |
| K052422 | THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) | Sep 27, 2005 | Substantially Equivalent | FLOW X-RAY CORP. |
| K041385 | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | Jun 07, 2004 | Substantially Equivalent | SCHICK TECHNOLOGIES, INC. |
| K960819 | HELIODENT DS | Mar 29, 1996 | Substantially Equivalent | PELTON & CRANE CO. |
| K960028 | ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM | Mar 01, 1996 | Substantially Equivalent | DENTSPLY INTL. |
| K953936 | ATLANTIS | Dec 28, 1995 | Substantially Equivalent | TROPHY RADIOLOGIE |
| K954565 | EXPLOR-X (AZTEH) HF | Oct 27, 1995 | Substantially Equivalent | CHICAGO X-RAY SYSTEMS, INC. |
| K951734 | LUMIX 70B | Jul 20, 1995 | Substantially Equivalent | EMIX U.S.A., INC. |
| K950533 | TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY | Jun 30, 1995 | Substantially Equivalent | TROPHY RADIOLOGIE |
| K950532 | TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY | Apr 19, 1995 | Substantially Equivalent | TROPHY RADIOLOGIE |
| K950667 | AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER | Apr 06, 1995 | Substantially Equivalent | CHICAGO X-RAY SYSTEMS, INC. |
| K950030 | HELIODENT MD | Feb 03, 1995 | Substantially Equivalent | PELTON & CRANE CO. |
| K934645 | RADWORKS | Aug 17, 1994 | Substantially Equivalent | RADWORKS CORP. |
| K936068 | ORTHOPHOS 3/ ORTHOPHOS 3C | Jul 29, 1994 | Substantially Equivalent | PELTON & CRANE CO. |
| K933455 | COMPUTED ORAL RADIOLOGY SYSTEM | Jan 31, 1994 | Substantially Equivalent | SCHICK TECHNOLOGIES, INC. |
| K931486 | INTREX VSK INTERORAL DENTAL X-RAY UNIT | Nov 23, 1993 | Substantially Equivalent | KEYSTONE X-RAY, INC. |
| K931717 | YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY | Sep 20, 1993 | Substantially Equivalent | KAYCOR INTL., LTD. |
| K930925 | INTREX INTERORAL DENTAL X-RAY UNIT | Jul 13, 1993 | Substantially Equivalent | KEYSTONE X-RAY, INC. |
| K930761 | IMAGE-X 70 INTRAORAL X-RAY SYSTEM | May 25, 1993 | Substantially Equivalent | AFP IMAGING CORP. |
| K923307 | HEALTHPAK X-RAY SOX BARRIERS | Jan 21, 1993 | Substantially Equivalent | HEALTHPAK, INC. |
| K900681 | PANORAMIC MODEL X-CALIBER X-RAY | May 23, 1990 | Substantially Equivalent | BELMONT EQUIPMENT CORP. |
| K896963 | TRIMODE SP DENTAL INTRA ORAL X-RAY | Jan 22, 1990 | Substantially Equivalent | TEMPO TECHNOLOGY, INC. |
| K896024 | MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE | Jan 22, 1990 | Substantially Equivalent | MDT DIAGNOSTIC CO. |
| K883354 | VARIABLE KV INTREX VSK 60 - 90 KVP | Dec 21, 1988 | Substantially Equivalent | KEYSTONE X-RAY, INC. |
| K882379 | MINIM-X 2001-CIAS & MINIM-X 2002-CIAS | Sep 09, 1988 | Substantially Equivalent | DENTOMAR, INC. |
| K861328 | NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY | Apr 24, 1986 | Substantially Equivalent | BELMONT EQUIPMENT CORP. |
| K852019 | BELMONT AUTOPAN-PAN ORAMIC, 098E CEPHALOMETRIC-RAD | Jun 05, 1985 | Substantially Equivalent | BELMONT EQUIPMENT CORP. |
| K834279 | ACURAY 071A DENTAL INTRAORAL X-RAY | Dec 29, 1983 | Substantially Equivalent | BELMONT EQUIPMENT CORP. |
| K833241 | INTREX | Oct 28, 1983 | Substantially Equivalent | PENNWALT CORP. |
| K832065 | ACURACY 071, DENTAL, INTRAORAL-X-RAY | Sep 12, 1983 | Substantially Equivalent | BELMONT EQUIPMENT CORP. |
| K800063 | XR-710 | Mar 03, 1980 | Substantially Equivalent | PENNWALT CORP. |
| K792535 | PORTARAY | Jan 28, 1980 | Substantially Equivalent | SIEMENS CORP. |
| K792437 | RAFLEX 70 | Jan 09, 1980 | Substantially Equivalent | MDT CORP., INC. |
| K792307 | DENTIX DENTAL X-RAY UNIT | Jan 09, 1980 | Substantially Equivalent | PRECISE OPTICS |
| K791014 | DENTAL XERORADIOGRAPHY | Sep 04, 1979 | Substantially Equivalent | XEROX MEDICAL SYSTEMS |
| K781630 | GE-700 INTRA ORAL X-RAY SYSTEM | Dec 04, 1978 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K772184 | X-RAY SYSTEM FOR DENTAL APPLICATION | Dec 22, 1977 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K770345 | X-RAY TUBE - PANOBEAM | Mar 08, 1977 | Substantially Equivalent | THORO-RAY, INC. |
| K760323 | X-RAY UNIT, DENTAL DIAGNOSTIC | Aug 03, 1976 | Substantially Equivalent | THE S. S. WHITE CO. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.