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FDA 510(k)

ORTHOPHOS XG 3D / CEPH

K-Number: K103711 · 2011-03-22

ApplicantSirona Dental Systems GmbH
Decision Date2011-03-22
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORTHOPHOS XG 3D / CEPH is the device name listed in this FDA 510(k) record. The listed applicant is Sirona Dental Systems GmbH. It received FDA 510(k) clearance on 2011-03-22 under 510(k) number K103711. 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 ORTHOPHOS XG 3D / CEPH?

ORTHOPHOS XG 3D / CEPH is a medical device that received FDA 510(k) clearance on 2011-03-22. The listed applicant is Sirona Dental Systems GmbH. The 510(k) number is K103711.

When did ORTHOPHOS XG 3D / CEPH receive FDA 510(k) clearance?

ORTHOPHOS XG 3D / CEPH received FDA 510(k) clearance on 2011-03-22, under 510(k) number K103711.

Who is the listed applicant for ORTHOPHOS XG 3D / CEPH?

The FDA 510(k) record lists Sirona Dental Systems GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHOPHOS XG 3D / CEPH?

The FDA product code for ORTHOPHOS XG 3D / CEPH is OAS.

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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.

K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.K260662Dental Cone Beam Computed Tomography SystemYofo 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.

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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