← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
OAS — X-Ray, Tomography, Computed, Dental
Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.
DEVICE CLASS
Class II
REGULATION
21 CFR 892.1750
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
16
510(K)/PMA CLEARANCES
510k: 16
0
RECALL ENTRIES
Recent clearances
K250839Changzhou Boen Zhongding Medical Technology Co., Ltd. · 510k2026-06-11
K260662Yofo Medical Technology Co., Ltd. · 510k2026-06-04
K253935medXion Technologies, Inc. · 510k2026-05-15
K260462Ray Co., Ltd. · 510k2026-04-09
K260093VATECH Co., Ltd. · 510k2026-03-31
K252353Cefla S.C. · 510k2026-03-10
K253959Dentsply Sirona · 510k2026-02-05
K251798Ray Co., Ltd. · 510k2025-11-25
Related on SPEQ
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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