Cleared Traditional

K002062 - SAMSUNG 10DR IMPLANT SYSTEM

K002062 is an FDA 510(k) clearance for SAMSUNG 10DR IMPLANT SYSTEM, manufactured by Samsung Sds Co., Ltd.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K002062 · Samsung Sds Co., Ltd. · Radiology device
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Nov 2000
Decision
126d
Days
Class 2
Risk

K002062 is an FDA 510(k) clearance for the SAMSUNG 10DR IMPLANT SYSTEM. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Samsung Sds Co., Ltd. (Aubrey, US). The FDA issued a Cleared decision on November 9, 2000 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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 Samsung Sds Co., Ltd. devices

FDA 510(k) Submission Details - K002062

510(k) Number K002062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2000
Decision Date November 09, 2000
Days to Decision 126 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 107d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - EHD Unit, X-ray, Extraoral With Timer

All 121
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K002062.
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HELIODENT VARIO
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