← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

EHD — Unit, X-Ray, Extraoral With Timer

DEVICE CLASS
Class II
REGULATION
21 CFR 872.1800
MEDICAL SPECIALTY
Dental
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
8
510(K)/PMA CLEARANCES
510k: 8
0
RECALL ENTRIES

Recent clearances

K260367PDX Co., Ltd. · 510k2026-05-27
K253864Dental Imaging Technologies Corporation · 510k2026-03-20
K252110Guangzhou Ajax Medical Equipment Co., Ltd. · 510k2026-03-12
K254018Guilin Refine Medical Instrument Co., Ltd. · 510k2026-02-19
K252909Ningbo Runyes Medical Instrument Co., Ltd. · 510k2026-02-03
K251438Guilin Woodpecker Medical Instrument Co., Ltd. · 510k2025-09-04
K242185Raypia Co., Ltd. · 510k2024-12-04
K242591DRTECH Corporation · 510k2024-11-01

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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