Cleared Traditional

K120948 - PREXION 3D

K120948 is an FDA 510(k) clearance for PREXION 3D, manufactured by The Yoshida Dental Mfg. Co., Ltd.. The device is a Class 2 Radiology device with product code OAS cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K120948 · The Yoshida Dental Mfg. Co., Ltd. · Radiology device
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Dec 2012
Decision
267d
Days
Class 2
Risk

K120948 is an FDA 510(k) clearance for the PREXION 3D. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by The Yoshida Dental Mfg. Co., Ltd. (Tokyo, JP). The FDA issued a Cleared decision on December 21, 2012 after a review of 267 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all The Yoshida Dental Mfg. Co., Ltd. devices

FDA 510(k) Submission Details - K120948

510(k) Number K120948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2012
Decision Date December 21, 2012
Days to Decision 267 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 107d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OAS Device Classification - Class 2, Special Controls

Product Code OAS X-ray, Tomography, Computed, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OAS X-ray, Tomography, Computed, Dental

All 126
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K120948.
PREXION3D ECLIPSE
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OP300
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PHT-6500
K122606 · Mtechgroup · Nov 2012
PAX-UNI3D, PHT-7500
K121400 · VATECH Co., Ltd. · Aug 2012