Cleared Traditional

K082410 - MASTER3DS

K082410 is an FDA 510(k) clearance for MASTER3DS, manufactured by E-Woo Technology. The device is a Class 2 Radiology device with product code OAS cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K082410 · E-Woo Technology · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
71d
Days
Class 2
Risk

K082410 is an FDA 510(k) clearance for the MASTER3DS. Classified as X-ray, Tomography, Computed, Dental (product code OAS), Class II - Special Controls.

Submitted by E-Woo Technology (Flintville, US). The FDA issued a Cleared decision on October 31, 2008 after a review of 71 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.

FDA 510(k) Submission Details - K082410

510(k) Number K082410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2008
Decision Date October 31, 2008
Days to Decision 71 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
36d faster than avg
Panel avg: 107d · This submission: 71d
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 134
Devices cleared under the same product code (OAS) and FDA review panel - the closest regulatory comparables to K082410.
DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D
K090467 · VATECH Co., Ltd. · Jan 2010
X-RAY, TOMOGRAPHY, COMPUTED, DENTAL
K083917 · Suni Medical Imaging, Inc. · Jun 2009
COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D
K090171 · E-Woo Technology · Apr 2009
PAX-500
K082350 · VATECH Co., Ltd. · Oct 2008
FINECUBE DENTAL CT
K063622 · The Yoshida Dental Mfg. Co., Ltd. · Feb 2007
VOLUMETRIC TOMOGRAPHY
K063773 · Instrumentarium Dental, Inc. · Jan 2007
K082410 · MASTER3DS
Download PDF FDA Summary E-Woo Technology