PAX-FLEX3D, PHT-7000

FDA 510(k) K121412 · VATECH Co., Ltd.

Substantially Equivalent

510(k) numberK121412

Submission

Device name
PAX-FLEX3D, PHT-7000
Applicant
VATECH Co., Ltd.
Houston, TX, US
Received
May 11, 2012
Decision date
June 8, 2012
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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More from Fussen Technology Co., Ltd.

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K231796Grreen X 12 (Model: PHT-75CHS)OAS · Special 07/19/2023SE
K223058EzRay Air 2 Wall (Model: VEX-S350W)EHD · Special 10/26/2022SE
K213462EzRay M18 (Model: VMX-P400)IZL · Traditional 02/11/2022SE
K210329Green X 18(Model : PHT-75CHS)OAS · Special 02/18/2021SE
K203667EzRay M (Model: VMX-P300)IZL · Traditional 02/02/2021SE
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Questions and answers

When was PAX-FLEX3D, PHT-7000 cleared by the FDA?

PAX-FLEX3D, PHT-7000 (K121412) received a 510(k) decision of Substantially Equivalent on June 8, 2012, 28 days after the submission was received.

What is the product code of K121412?

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