Dental Device Guide
Add your company

Diagnostic devices · 21 CFR 872 Subpart B

Intraoral X-Ray Unit

FDA device type “Unit, X-Ray, Intraoral”.

FDA codeEAPClass221 CFR872.1810Pathway510(k)CategoryDental X-ray units
Companies listing it
95 makers
Brands and models
10
510(k) clearances
420 in five years
FDA name
Unit, X-Ray, Intraoral
1976: 11977: 21978: 11979: 11980: 41983: 31985: 11986: 11988: 21990: 31993: 51994: 31995: 71996: 22004: 12005: 12008: 12009: 12011: 12012: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list EAP

9 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Dentsply Sirona, Inc.United StatesMaker—1482026
Carestream Dental LLCUnited StatesMakerDENTRA III · RIOSensor+ · RVG 142 · RVG 5200 · +2112020
Prime Dental Manufacturing, Inc.United StatesMaker—92012
O&S Dental IncUnited StatesMaker———
Zentech Manufacturing, IncUnited StatesMaker———
Osstem Implant Co., Ltd.South KoreaContract manufacturerS2 (digital intra-oral X-ray sensor)682026
Ray Co., Ltd,South KoreaContract manufacturerRIOSensor+212026
Hdx Will Corp.South KoreaForeign exporterDENTRA III62021
Ray America Inc.United StatesListerRIOSensor+ Intraoral X-ray unit——

510(k) clearances

Decided510(k)DeviceApplicant
7 Feb 2012K113360MEDICAL IMAGE PROCESSING UNITHumanray Co,Ltd
30 Jun 2011K102573PROVU (TM) DENTAL X-RAY SYSTEMAdvanced Image Science, Inc.
30 Nov 2009K093453MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.
13 May 2008K080738DENTRON SENSORDentron Systems, LLC
27 Sep 2005K052422THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)Flow X-Ray Corp.
7 Jun 2004K041385MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.
29 Mar 1996K960819HELIODENT DSPelton & Crane
1 Mar 1996K960028ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEMDentsply Intl., Inc.
28 Dec 1995K953936ATLANTISTrophy Radiologie
27 Oct 1995K954565EXPLOR-X (AZTEH) HFChicago X-Ray Systems, Inc.
20 Jul 1995K951734LUMIX 70BEmix U.S.A., Inc.
30 Jun 1995K950533TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHYTrophy Radiologie
19 Apr 1995K950532TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHYTrophy Radiologie
6 Apr 1995K950667AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMERChicago X-Ray Systems, Inc.
3 Feb 1995K950030HELIODENT MDPelton & Crane
17 Aug 1994K934645RADWORKSRadworks Corp.
29 Jul 1994K936068ORTHOPHOS 3/ ORTHOPHOS 3CPelton & Crane
31 Jan 1994K933455COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.
23 Nov 1993K931486INTREX VSK INTERORAL DENTAL X-RAY UNITKeystone X-Ray, Inc.
20 Sep 1993K931717YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAYKaycor Intl., Ltd.
13 Jul 1993K930925INTREX INTERORAL DENTAL X-RAY UNITKeystone X-Ray, Inc.
25 May 1993K930761IMAGE-X 70 INTRAORAL X-RAY SYSTEMAfp Imaging Corp.
21 Jan 1993K923307HEALTHPAK X-RAY SOX BARRIERSHealthpak, Inc.
23 May 1990K900681PANORAMIC MODEL X-CALIBER X-RAYBelmont Equipment Corp.
22 Jan 1990K896963TRIMODE SP DENTAL INTRA ORAL X-RAYTempo Technology, Inc.
22 Jan 1990K896024MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINEMdt Diagnostic Co.
21 Dec 1988K883354VARIABLE KV INTREX VSK 60 - 90 KVPKeystone X-Ray, Inc.
9 Sep 1988K882379MINIM-X 2001-CIAS & MINIM-X 2002-CIASDentomar, Inc.
24 Apr 1986K861328NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAYBelmont Equipment Corp.
5 Jun 1985K852019BELMONT AUTOPAN-PAN ORAMIC, 098E CEPHALOMETRIC-RADBelmont Equipment Corp.
29 Dec 1983K834279ACURAY 071A DENTAL INTRAORAL X-RAYBelmont Equipment Corp.
28 Oct 1983K833241INTREXPennwalt Corp.
12 Sep 1983K832065ACURACY 071, DENTAL, INTRAORAL-X-RAYBelmont Equipment Corp.
3 Mar 1980K800063XR-710Pennwalt Corp.
28 Jan 1980K792535PORTARAYSiemens AG
9 Jan 1980K792437RAFLEX 70Mdt Corp., Inc.
9 Jan 1980K792307DENTIX DENTAL X-RAY UNITPrecise Optics
4 Sep 1979K791014DENTAL XERORADIOGRAPHYXerox Medical Systems
4 Dec 1978K781630GE-700 INTRA ORAL X-RAY SYSTEMGeneral Electric Co.
22 Dec 1977K772184X-RAY SYSTEM FOR DENTAL APPLICATIONGeneral Electric Co.
8 Mar 1977K770345X-RAY TUBE - PANOBEAMThoro-Ray, Inc.
3 Aug 1976K760323X-RAY UNIT, DENTAL DIAGNOSTICThe S. S. White Co.

Official records: FDA product classification for EAP · 21 CFR 872.1810.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026