Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Dental Computed Tomography X-ray System

K-Number: K251842 · 2025-11-13

ApplicantFussen Technology Co., Ltd.
Decision Date2025-11-13
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Dental Computed Tomography X-ray System is a medical device manufactured by Fussen Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-11-13 under approval number K251842. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental Computed Tomography X-ray System?

Dental Computed Tomography X-ray System is a medical device that received FDA 510(k) clearance on 2025-11-13. It is manufactured by Fussen Technology Co., Ltd.. The 510(k) number is K251842.

When was Dental Computed Tomography X-ray System approved by the FDA?

Dental Computed Tomography X-ray System received FDA 510(k) clearance on 2025-11-13, under approval number K251842.

What company makes Dental Computed Tomography X-ray System?

Dental Computed Tomography X-ray System is manufactured by Fussen Technology Co., Ltd..

What is the FDA product code for Dental Computed Tomography X-ray System?

The FDA product code for Dental Computed Tomography X-ray System is OAS.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT01421953 Assessment of 4D 18F-FDG PET-CT in Radiotherapy for Non Small Cell Lung Cancers COMPLETED NCT07608406 Modified Versus Clear Twin Block for Skeletal Class II Malocclusion NOT_YET_RECRUITING NCT05145426 Investigation of Low-intensity Focused Ultrasound for Human Pain Management COMPLETED NCT07608380 Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures ENROLLING_BY_INVITATION NCT07605286 Soft Tissue Augmentation Around Dental Implants COMPLETED

Related Devices (Code: OAS)

K161900HYPERION X5Cefla S.C. K160166X-MIND triumDe Gotzen S.R.L. K162085i-CAT FLX V series / KaVo 3D eXam+ V seriesImaging Sciences International K160882PaX-i3D Green Premium (Model: PCT-90LH)VATECH Co., Ltd. K162660Green Smart (Model: PHT-35LHS)VATECH Co., Ltd. K161881PreXion3D ExcelsiorPrexion Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑