Product code EHD— Dental
DENTAL X-RAY UNIT
- Classification name
- Unit, X-Ray, Extraoral With Timer
- Device class
- Class 2
- Regulation
- 21 CFR 872.1800
- Advisory panel
- Dental
- Total cleared
- 190
- First cleared
- Most recent
Market context for product code EHD
FDA has cleared devices under product code EHD between 1977 and 2026, filed by 120 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code EHD
Recent clearances under product code EHD
1–100 of 190- K260367 — Portable Dental X-ray System Model PDX nova
- K253864 — NOMAD Pro 3
- K252110 — Dental X-RAY Unit (AJX200)
- K254018 — Portable Dental X-ray Device (GT-1)
- K252909 — Diagnostic X-Ray Equipment Model POCT22
- K251438 — Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
- K242185 — Rextar Pro
- K242591 — XERO-alpha
- K241963 — WERAY
- K241305 — LifeRay Intraoral Handheld X-ray System
- K240759 — REMEX-GR100
- K233914 — XVbeam2000
- K233395 — Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)
- K231055 — x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)
- K232085 — DVAS (DVAS-M, DVAS-W)
- K232012 — N1
- K232068 — HyperLight Portable X-ray Unit
- K231449 — Portable X-ray System Model Ray98(P)
- K223780 — Lumos 3DX
- K221587 — DHX-70H, XTG-70H
- K223010 — Portable X-ray System
- K222569 — Ai Ray Dental X-Ray Device
- K223058 — EzRay Air 2 Wall (Model: VEX-S350W)
- K220579 — Hybrid C70
- K222274 — FONA XDC
- K221286 — CLAROX
- K221233 — DT-703
- K220574 — HYBRID S70
- K213282 — ERI Handheld Dental X-ray System (Model AG100)
- K211014 — Portray
- K201800 — Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)
- K200182 — EzRay Air Portable (Model: VEX-P300)
- K192700 — Xcam
- K190935 — EZER, Portable X-ray System
- K180671 — MINE
- K190357 — Star-X, Intraoral X-ray System
- K182206 — RiX70 DC
- K181891 — Portable X-ray System (Model: MiniX-V, Mini X-S)
- K180561 — MobileX Portable X-ray System
- K172928 — Portable X-ray System
- K172810 — PORT-X IV
- K173319 — KaVo NOMAD Pro 2 Handheld X-ray System
- K170967 — Intraskan DC Plus
- K163705 — EzRay Air W
- K163519 — RX DC
- K161063 — EzRay Air (Model VEX-P300)
- K160458 — BI IMAGE-X EVOLUTION
- K152859 — Portable X-ray System (Model: MINIX-V / MINIX-S)
- K141293 — PHOT-X IIS MODEL 505
- K141497 — PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)
- K132378 — X-MIND UNITY
- K130109 — ENDOGRAPH DC
- K132041 — REXTAR X
- K122124 — PORTABLE X-RAY SYSTEM
- K122016 — REXTAR, REXTAR LCD
- K123493 — VEX-S 100W INTRAORAL X-RAY SYSTEM
- K122582 — DENTAL X-RAY Z70 (3 models)
- K111330 — AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY
- K103600 — PORTABLE X-RAY SYSTEM
- K103579 — INTRA SKAN DC
- K093105 — VISTEO
- K091255 — MINXRAY, MODEL: BPD60
- K093240 — BELRAY II
- K092772 — PORTABLE X-RAY SYSTEM, MODEL HAND-RAY
- K092103 — DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)
- K091197 — PLANMECA PROSENSOR
- K090749 — ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191
- K082875 — PORTABLE X-RAY SYSTEM, MODEL DXR -1
- K083344 — HELIODENT PLUS
- K082167 — PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX
- K081899 — ANYRAY PORTABLE X-RAY SYSTEM
- K081664 — NOMAD PRO X-RAY SYSTEM
- K080076 — RX DC X-RAY UNIT
- K063121 — PORTABLE X-RAY SYSTEM, MODEL PORT-X II
- K060640 — DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM
- K060292 — KODAK MODELS 2100 AND 2200
- K051795 — NOMAD DENTAL X-RAY SYSTEM
- K051464 — PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)
- K050255 — ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4
- K043104 — KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0
- K043612 — ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D
- K050019 — IN EXAM INTRAORAL DENTAL X-RAY SYSTEM
- K043557 — MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS
- K043136 — ELITY 70 X-RAY
- K043307 — CRANEX D
- K043092 — PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015
- K042260 — PHOT-X II, MODEL 303
- K040382 — CRANEX BASEX D OR CRANEX EXCEL D
- K040748 — ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM
- K033755 — MINRAY
- K040556 — TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY
- K033690 — TROPHYPAN AND TROPHYPAN C
- K033073 — ORTHOPHOS XG DS/CEPH
- K032355 — ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW
- K031448 — RSV (RADIOLOGY SYSTEM VISIODENT
- K030634 — ENDOS DC
- K031802 — CORIX 70 PLUS-USV
- K031118 — INTRAOS 70
- K024285 — A/T X-RAY 70
- K030647 — EVA DIGITAL DENTAL X-RAY SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.