Dental Cone Beam Computed Tomography System

FDA 510(k) K260662 · Yofo Medical Technology Co., Ltd.

Substantially Equivalent

510(k) numberK260662

Submission

Device name
Dental Cone Beam Computed Tomography System
Applicant
Yofo Medical Technology Co., Ltd.
Hefei, CN
Received
March 2, 2026
Decision date
June 4, 2026
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OAS – X-Ray, Tomography, Computed, Dental
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1750
Specialty
Radiology

Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.

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K252353myray ProXIma X6OAS · Traditional Cefla S.C.03/10/2026SE
K253959Primevision 3DOAS · Traditional Dentsply Sirona02/05/2026SE
K251798RCT700OAS · Traditional Ray Co., Ltd.11/25/2025SE
K251842Dental Computed Tomography X-ray SystemOAS · Traditional Fussen Technology Co., Ltd.11/13/2025SE
K250060GT300; GT300-COAS · Traditional Genoray Co., Ltd.10/08/2025SE

More from Genoray Co., Ltd.

510(k)DeviceDecision
K243337Dental Cone Beam Computed Tomography SystemOAS · Traditional 04/17/2025SE

Questions and answers

When was Dental Cone Beam Computed Tomography System cleared by the FDA?

Dental Cone Beam Computed Tomography System (K260662) received a 510(k) decision of Substantially Equivalent on June 4, 2026, 94 days after the submission was received.

What is the product code of K260662?

The FDA product code is OAS – X-Ray, Tomography, Computed, Dental, a Class II (moderate risk) device regulated under 21 CFR 892.1750.