Cleared Traditional

K063622 - FINECUBE DENTAL CT (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K063622 · The Yoshida Dental Mfg. Co., Ltd. · Radiology device
Feb 2007
Decision
65d
Days
Class 2
Risk

K063622 is an FDA 510(k) clearance for the FINECUBE DENTAL CT. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by The Yoshida Dental Mfg. Co., Ltd. (Deer Field, US). The FDA issued a Cleared decision on February 8, 2007 after a review of 65 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K063622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2006
Decision Date February 08, 2007
Days to Decision 65 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 128d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 25
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