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FDA 510(k)

Dental Cone Beam Computed Tomography System

K-Number: K260662 · 2026-06-04

ApplicantYofo Medical Technology Co., Ltd.
Decision Date2026-06-04
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Dental Cone Beam Computed Tomography System is the device name listed in this FDA 510(k) record. The listed applicant is Yofo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K260662. 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 Cone Beam Computed Tomography System?

Dental Cone Beam Computed Tomography System is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is Yofo Medical Technology Co., Ltd.. The 510(k) number is K260662.

When did Dental Cone Beam Computed Tomography System receive FDA 510(k) clearance?

Dental Cone Beam Computed Tomography System received FDA 510(k) clearance on 2026-06-04, under 510(k) number K260662.

Who is the listed applicant for Dental Cone Beam Computed Tomography System?

The FDA 510(k) record lists Yofo Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Cone Beam Computed Tomography System?

The FDA product code for Dental Cone Beam Computed Tomography System is OAS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04686084Dual Energy Cone-Beam Computed Tomography (DE-CBCT) Assessment of Jaw Bone DensityCOMPLETEDNCT06308640Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed TomographyACTIVE_NOT_RECRUITINGNCT06481761The Effectiveness of Double-slot Brackets Versus Single-slot Brackets on the Rate of Canine RetractionCOMPLETEDNCT07240493BMP Effect on Implant Stability and Marginal Bone Level After Immediate PlacementCOMPLETEDNCT07513792The Impact of a 3D Imaging Tool on Reducing Gum Recession During Orthodontic Treatment With AlignersRECRUITINGNCT07518615Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System FalconRECRUITING

Other records listing Yofo Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243337Dental Cone Beam Computed Tomography System

Related Devices (Code: OAS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.K252353myray ProXIma X6Cefla S.C.K253959Primevision 3DDentsply Sirona

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.

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