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FDA 510(k)

PREXION 3D

K-Number: K120948 · 2012-12-21

ApplicantThe Yoshida Dental Mfg. Co., Ltd.
Decision Date2012-12-21
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PREXION 3D is the device name listed in this FDA 510(k) record. The listed applicant is The Yoshida Dental Mfg. Co., Ltd.. It received FDA 510(k) clearance on 2012-12-21 under 510(k) number K120948. 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 PREXION 3D?

PREXION 3D is a medical device that received FDA 510(k) clearance on 2012-12-21. The listed applicant is The Yoshida Dental Mfg. Co., Ltd.. The 510(k) number is K120948.

When did PREXION 3D receive FDA 510(k) clearance?

PREXION 3D received FDA 510(k) clearance on 2012-12-21, under 510(k) number K120948.

Who is the listed applicant for PREXION 3D?

The FDA 510(k) record lists The Yoshida Dental Mfg. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREXION 3D?

The FDA product code for PREXION 3D is OAS.

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Other records listing The Yoshida Dental Mfg. 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.

K182198Panoura X-ERA PF/NF/MFK122199PREXION3D ECLIPSEK120932OPELASER PRO II AND THE OPELASER LITE IIK111231PANOURA 18SK063622FINECUBE DENTAL CTK000577YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA

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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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