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FDA 510(k)

VOLUMETRIC TOMOGRAPHY

K-Number: K063773 · 2007-01-31

ApplicantInstrumentarium Dental, Inc.
Decision Date2007-01-31
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VOLUMETRIC TOMOGRAPHY is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium Dental, Inc.. It received FDA 510(k) clearance on 2007-01-31 under 510(k) number K063773. 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 VOLUMETRIC TOMOGRAPHY?

VOLUMETRIC TOMOGRAPHY is a medical device that received FDA 510(k) clearance on 2007-01-31. The listed applicant is Instrumentarium Dental, Inc.. The 510(k) number is K063773.

When did VOLUMETRIC TOMOGRAPHY receive FDA 510(k) clearance?

VOLUMETRIC TOMOGRAPHY received FDA 510(k) clearance on 2007-01-31, under 510(k) number K063773.

Who is the listed applicant for VOLUMETRIC TOMOGRAPHY?

The FDA 510(k) record lists Instrumentarium Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VOLUMETRIC TOMOGRAPHY?

The FDA product code for VOLUMETRIC TOMOGRAPHY 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

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

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